NFDA-approved clinical trials at UCLA and UCSD: Chinese Herbs and Mushrooms for Covid-19!

good evening everyone welcome to tonight's talk about a clinical trial approved to study chinese herbs and mushrooms for kobe 19. tonight's talk will focus on chinese herbal portion of the study but hopefully we'll be doing another talk hopefully in october focusing on the medicinal mushroom arm of this of the study my name is jack miller i'm the chairman of pacific college of health and science pacific college is co-hosting this live webinar with lhasa oms i have to say that lhasa has been a great friend to the college and to this profession there always is a supporter of pacific symposium which is coming up very soon and always very very generous to the attendees that go to the symposium so um and also they sell they will be selling some of the formulas mentioned here tonight okay this webinar is a natural progression from the series of webinars that we did with lhasa and dr john chen over the past year or more about the herbal treatment of coven 19. you can find those previous webinars on pacific college's youtube channel okay john chen will introduce the speakers tonight who will include the investigators from the university of california gordon sachs a good friend of our college andrew schubbach and long cow they will be joined towards the end of the presentation for live q a panel discussion with pacific professor emeritus our good friend zev rosenberg and zev was also very instrumental in the development of the plan for this study you can put your questions in the youtube chat box okay and we will pose them to the panelists during the q a if the question is for a particular speaker please note that i'll also mention that cynthia knipers our director of outreach and alumni services will be that moderator so if you hear someone talking that's not me it's most likely uh cynthia um and i should also mention if you're not part of our alumni network and you're an alum of pacific college introduce yourself to cynthia and she'll get you connected so um to start i'd like to introduce john chen john is a recognized authority in both western pharmacology and chinese herbal medicine and is taught at many of the chinese medicine colleges and he's also served as a worldwide resource for chinese medicine he is the author of a materia medica and formulas book that are foundational in chinese medicine learning he's considered a foremost authority on chinese herbal treatment for coven 19 which if you listen to the previous webinars you will agree with heartily his generosity to the profession for sharing that knowledge through those webinars has been incredible so john it's really my honor and pleasure to introduce you to this broad audience tonight oh thank you jan and also thank you to pacific college and lhasa oms for co-hosting this event this is the fourth or fifth webinars that we are doing on chinese medicine and cover 19 and it's just a progression of all the things that we have done to bring us to this point okay so at this moment i'm going to share with you my powerpoint all right so i'm going to do the introduction today but the main speakers will be dr andrew schubov golden sags and also long cow they really are the ones that deserve all the credit for today's talk as well as all the work that we have done okay so um what i will do here is i will zoom out just a bit to give our audience audience today a chance to see the bigger picture and at the same time i'll give a give you a quick introduction into the herbal formula that they are studying in case if you are not familiar with it uh hopefully that will uh set the stage a little bit better as the three main speakers start and talk about all the things they have done in the last year or so all right so um this here is a book called the guidance for coronavirus disease and this is a book published by the chinese government and what it has done is basically taking all the experience that are compiled by city provincial and also national level of all the things they have done to treat 19 and put it into one version so all the practitioner can easily access it this book is available in both english and also chinese so regardless of what your background is you should be able to access a version that you can read uh if you click on the hyperlink uh it will take you right to where the book is and you can download it for free all right and specifically for the tcm part what you will notice is that it's true to the root of chinese medicine in that it breaks down the disease into many different types and many different pattern differentiation as well as treatment so you have the medical observation period clinical treatment period whether it's mild moderate severe or critical and the last part should actually be a big bullet which is a recovery period so depending on their signs and symptom and tcm presentation the treatment is going to be different but what happened in this particular case is cover 19 comes down so fast and so sudden so in china in when this first happened they don't really have the luxury to see each person individually take the time look at the town take the pause especially since many practitioners were in hazmat suit so in essence what they have to do is design a one-size-fits-all formula so they can quickly treat as many people as possible so what you have here is under the second bullet there is a line that says general type of covet for the mile to model so what they have done is they devised a formula called ching fei pai du tang which is the modified which is the clear the lung and detoxifying decoction so this is what they fell is the most suitable for most everyone who have a mild to moderate case of copenhagen so this is the one-size-fits-all this is the first line treatment that they were using for almost all patients with cold all right and the idea behind this one formula was they took the essence of four formulas and they and then modify it a bit and combine it into one and those four additional formulas [Music] and the english translation of these four formulas are right here on the powerpoint so i won't repeat them but this formula or four classic formula is trying to do is to treat both the cause and also the symptoms to help to eliminate the virus and also alleviate many of the signs and symptoms so basically how to clear lungs ventilate the lung to eliminate the toxin eliminate the phlegm and harmonize the patient and so on all right so that's the overall goal to help to treat the early to mid stage of cover 19. and then if you dive one step deeper you will notice that this is a very large formula with 21 individual ingredients so they were quite aggressive with the treatment you know it's not a small dose it's a large dose with many different herbs and they were giving this formula as an herbal decoction all right and in fact they had very good success with this formula and what happened is of course covert starts to spread to all the risks of the province in china and very quickly all throughout the world so what happened is many countries try to copy the same formula and give it to their citizens but what happened is there were challenges and the main reason is because there were three herbs that were very difficult to source either because they are illegal or they are unavailable and those three herbs are primarily mahwang herbal ephedra quantum hua and they contain different compounds that different governments around the world were considered to be too strong as a dietary supplement and therefore classified as a drug or they contain compounds that potentially may be more toxic or may cause certain adverse reactions and therefore they may or may not be available and that applies to the united states as well all right so if you do a google search what you'll find is that there are many different versions of this formula in capsule form in tablet form in the tincture form so the first thing i want to shout out to all the audience is that uh please don't listen to this presentation and just go out and buy a product or specifically for the um general public since this is on youtube uh don't just go out and buy this product and treat yourself because there are a lot of things that you need to know that you may not know so please go see a practitioner um before you decide to do anything and then as a practitioner uh please also keep in mind that these different versions of the product are not necessarily the same as what they used in china number one the formulation may be different the dosage is going to be different and dosage 4 may also be different so make sure you consider those factors before you decide what's best for the patient and i would say as a tcm practitioner the best thing to do is since we are not in a hurry to treat these patients we don't have hundreds or thousands of people at our doorstep at any given time the best thing to do is to take the time evaluate each and every patient see what their tcm pattern is and then treat the patient based on whatever is the best for their particular condition so that's the way to get the best result all right so uh at ucla and ucsd we had a lot of meeting also to try to determine what is the best way to use or modify this formula for use here in the united states so i will leave it to the speakers you know to get into the details but overall what we have come to is that after over a year of a lot of hard work fda has approved a clinical trial for us to begin to evaluate both the mushrooms and also the chinese herbal formula and that chinese herbal formula is the modified ching fei pai tu tang and that's why you see the m in front of the formula qfpd all right and this is a brief description of the drug approval process it's a very long and lengthy and challenging process and there is a chinese saying that a journey of a thousand miles must begin with one single step okay so with the fda's approval for us to begin this clinical trial i think that's a giant leap that we have just taken all right so with that um i will turn the presentation over to andrew schubach gordon sags and also long cow and i also have slides of all the accomplishments um so i won't take the time to read all them because if i do then i'm going to take away too much of the time for this presentation itself but in essence uh dr andrew schubov and golden golden sack are the primary investigator for this particular study and lan cow is the co-investigator specifically for the chinese herbal medicine part all right so with that i would like to go ahead and turn over the presentation to them thank you dr chan thank you uh jack miller so our story um andrew first slide our story begins in late december 2019 when we all first heard reports of a strange viral illness in wuhan china when i saw news reports a few weeks later that the disease had escaped wuhan and on the eve of chinese new year i realized as an epidemiologist that the disease had the potential to become a global pandemic and it was a really sickening feeling so uh fast forward to february 8 2020 that was the day that the university of california san diego sponsored the first university of california-wide integrative medicine research conference in la jolla its purpose was to promote collaborative research and to begin to promote the development of a research network across the five sister university of california medical centers with integrative medicine research program so looking up the coast from here you see san diego uc irvine ucla uc san francisco and uc davis so at the time of this conference kobet had already begun to spread in the u.s and everyone was very concerned uh during a break the conference i was talking with dr kit huey from ucla center for east west medicine and i remember him describing covet as something of a paper tiger and telling me that chinese herbal medicine had what already appeared to be a very effective treatment well that really resonated with me because at the time i was thinking non-stop about the development of a natural medicine approach to covid i was particularly interested in exploring the use of medicinal or polypore mushrooms known to have broad-based immune potentiating and antiviral effects and zev rosenberg and i had discussed the role of mushrooms in chinese herbal medicine for years anyway the upshot of the conference was an agreement to continue having regular meetings to foster cross-campus research collaboration and then next thing you know there was the shutdown uc san diego put all non-essential research that could not be done remotely on hiatus for an indefinite period that meant for those of us involved with the corrupt research endowment that our normal grant funding cycle would have to be put on hold in its place our board decided to instead have a special allocation for integrative research specifically focused on covid about that time i was introduced to dr andrew schubach from ucla who shared the core idea for the chinese herbal study and he's going to have a lot more to say about this in just a couple minutes i remember suggesting to dr shubov that we combine forces and find a way to meld these natural medicines into a combined study that we could then win support from the crep endowment next slide please the result was the birth of the mach 19 study mushrooms and chinese herbs for covid19 we're all natural so uh warp speed was beyond our reach but we were in a hurry to help address the medical problem of our lifetimes i also shared with dr shubhav that we had a research corps at ucsd that could step up to the plate to help support this study and i'd like to give a quick shout out to these other members of our team without whom the mach 19 study could not have been launched so the um the core provides a number of services as you can see here and they range from project management phlebotomy and so forth and um and really we would not have been able to do our study without the without the support and help of the members of our team so um anyway uh next slide please so there were really uh four studies that make up the mach 19 trial and just to frame them a little bit the first two are the two studies one of which is study two the study of chinese herbal formula for mild and moderately ill self-quarantining covid patients study one follows a similar design using mushrooms and both of these came in under the same ind investigational new drug approval from fda next slide please the third and fourth studies are both studies of mushrooms used in the context of vaccination as ways to enhance immunity beyond vaccines themselves we'll have much more to say about this when we do the uh presentation on the mushrooms in a few weeks um but for now i'd like to turn it over to dr shubhav and uh and so um uh dr shubov bob thank you thank you very much uh dr sachs and and dr chen as well for the um for the introductions uh i'm dr andrew schubov i'm um lead investigator on this clinical trial also uh um my day job is the director of inpatient integrative east west medicine at the ucla center at the santa monica hospital at ucla and um so let's start by kind of giving a little bit of a structure to the to the hour here um dr sax just gave an introduction of the mach 19 clinical trials uh focused on the the mushroom chinese the mushroom component of this i'm going to speak for the rest of the hour we're going to talk more specifically about the chinese herb component with an additional webinar in the next few few weeks or a month or two more focused on the chinese mushrooms i'm going to talk a little bit right now about the origins of the effort and of course more than anything just the intention behind what we're trying to do here um that'll help with the regulatory uh burdens uh kind of define how we ended up where where we're at now doctor i'm then going to give it to dr lon cow who's going to tell us more about the formula and some greater detail and also talk about the safety measures that are being implemented as well as some um examples of how we are using a pattern diagnosis in the con in the uh circumscribed within within the clinical trial she'll then pass it back to me we'll talk about the regulatory hurdles required to uh perform botanical drug research in the u.s um and this might help explain why there aren't more of these studies unfortunately if we have time at the end i'd like to explore some options for streamlining this process because uh this hopes to be just the you know one of many studies on these kinds of things uh quick clarifications just some housekeeping we should let you know that the fda approval for this extends only for the clinical trial so this is an fda ind approval um probably uh similar to say how the fda approved the clinical trial for mdma for ptsd but did not approve the broad use of that yet the fir the the ind application is the first step for broader approval um we should also say that the study is actively recruiting so we can't actually share any results yet from that that's hopefully coming in the next few months so let's talk about this clinical trial because this is this is um it comes from a very interesting place of course march 2020 and i'll ask you to do something painful here which is bring yourselves back to that moment in particular that moment when when this um kind of a news thing turned into a worldwide shutdown there was a moment where where all denial vanished and suddenly this is happening um and it was it was terrifying there was a lot of emotions there a lot of things a lot of upheaval and a lot of change happened very very rapidly and in my mind one of the reasons for such kind of out of the control fear uh was this idea that western medicine somehow wasn't there for us and i i speak as an internist i'm and i'm fully immersed in western medicine i consider myself a western medicine practitioner i appreciate and value western medicine it's been huge and it's been so successful over my generation that we now can expect that a heart attack or stroke can be reversed if we get to the hospital in time that's an enormous statement many cancers even though they're not curable or at least treatable major traumas are are survivable now and so when we're faced with a virus that somehow flies through all of these swiss cheese holes in the western medical system we're left with with nothing left with dark ages level of health here and it's terrifying it's a lot it's a lot for um it's a lot for the for our country certainly and certainly uh brought up feelings of panic and fear um now many of you uh i'm imagining because of the nature of this webinar in the audience we may have been drawn towards alternative medicine out of a kind of an understanding that there are some holes in western medicine that need filling but for the country as a whole it was it's very difficult to grasp this so um we at least in east west medicine and many of you i'm sure as well we're familiar with chinese medicine uh also in terms of its history as becoming as something that is uh capable of treating infectious disease in particular cold diseases was was something that's been known for millennia now and we were watching at the sidelines as we saw china was rolling out the use of chinese herbal medicine as an integrated approach in the uh the book that dr john chen had just referred to as the diagnosis and treatment um for cobin 19. chinese herbal medicine is very clearly integrated there and so we thought well this is a simple thing here's an opportunity where western where the whole country will finally start appreciating chinese medicine for what it is it's an option when um when we need these options and instead we didn't see that in fact we saw kind of you know more of a blind spot there was um it's almost like chinese medicine didn't exist it wasn't anywhere on the radar we looked at the websites that were available the literature coming out was more kind of judgmental you know like this is a scam kind of um articles that uh didn't properly represent what chinese medicine could do at that time at first we were kind of curious by this and eventually we ended up quite frustrated um and angry about this because this is something that that needs to be fixed this was uh not okay so we circled our wagons we had a meeting uh with the center for east west medicine among those of us that wanted to do something to change and of course everybody at this time wanted to do something to help and we were you know another one of these many groups um and initially we had three goals one was that we could become a resource for people wanting to learn more about chinese herbal medicine the other more obvious one is we would become a clinical source for uh for telemedicine herbal uh recommendations for cobin 19. and um uh the third was that um i had just started this inpatient east west medicine consult service i was working in the hospital and um my friends and co-workers were digging trenches for an impending onslaught people were quarantining from their families uh uh other people were flying to new york to be on the front lines we were watching what happened in italy and then what happened in new york was happening at this moment la was next we were terrified i wanted to be able to offer them some help so we brought this to our chair um and he swiftly shut it down specifically use the following terminology he said and actually before i say this know that this man is widely recognized as being one of the smartest minds at ucla and under his guidance uh the department has really done very well he says i certainly think that east-west has much to offer in promoting wellness however giving the impression that herbs can mitigate copen 19 does not seem evidence-based at this time and i believe that you should avoid such implications so we were clearly heartbroken um and then once we thought about this again we recognized that he's not wrong that the like dr chen was saying if we make a recommendation say for an herb um the environment of the country at that time was such that it would the misinformation would spread like wildfire and we will have people taking herbs that are not the right herbs that are not sourced correctly that might be frankly toxic out of the same desperation that that led people to seek increasingly toxic um medications and all sorts of things uh and that we will cause true genuine harm and so uh the term that he used was that it's not evidence-based at this time so we started looking at the evidence base we also found that it was lacking and not only it was lacking there wasn't really anything on the horizon that saw coming out and um this was more of a frustration than an actual call for for help but um call for us to do something about it but clearly there was something that needed to happen here and this is something that we might be better off doing than the other things so we started looking at the resources becoming available for chinese herbal medicine we found out we're not the best people to um uh to become a resource for for chinese medicine and covet dr chen is at the pacific college is vasa that the um uh lotus these are all groups that are doing a much better job we're not the best people to be an herbal clinic for covid you are so what was within our scope as the center for east west medicine our charge was to translate eastern medicine to the west and in this case the language spoken by the west was double-blind randomized controlled trials and these did not exist and so it wasn't about the herbs it's that we were speaking the wrong language we were speaking based on what would be called anecdotal evidence which may be millennia of experience but not doubled by minimize controls trial so what's needed with a mannerized control trial we first started um the first thought was to protect our hospital uh healthcare workers by offering them you ping peng-sun which is a um prophylactic medication or herbal formula um in the context of a clinical trial maybe put one hospital on it put one hospital not on it there's all sorts of statistical problems uh associated with that uh that made us choose not to and for more importantly it turned out that the infection rates among healthcare workers was actually lower than expected which was great so we decided to pivot we pivoted to um using the chinese medicine for active coping 19. we thought this might actually have an impact this might be one of these levers that might change the way that chinese medicine is perceived from the west that maybe this will finally shine a light on this this deep sense of under of knowledge that uh the west needs right now at this moment once they get in you know they learn more about that they might they might be able to open their eyes more broadly to chinese medicine there are some statistical reasons as well that made this easier to study a large hospitalization rate of 20 back then um and it was also uh doable it was feasible because we can uh confine the study to outpatients only and um the inpatient service there was just so many research trials happening on the in the hospital that it would have been impossible to do any research so we presented this plan um to the uc centers for integrative medicine uh and dr sax spoke more about how we got connected um and it just turned out that he had a uh very very very similar interest in studying mushrooms for copenhagen and he had a um he had a team he had uh support and it worked the rest is history we also connected with a few other uh centers lee hollander ruben um an acupuncturist at ucsf who did a tremendous amount of work with us early on uh to help uh help write the ind and try to malek at uci so with the four of us we had four centers for integrative medicine at ucf at the university of california and we were we were rolling at the end of march which was two extremely stressful weeks we had the following plan in place we had a multi-center double-blinded randomized control trial for coven 19 patients outpatients can find a home quarantine we would have two stages one would be safety feasibility and the second would be efficacy now the safety feasibility would be 33 patients which is larger than typical safety studies so that that would allow us to actually look at some outcomes of efficacy we would probably not actually meet statistical significance but this would give us a sense so that we can design our next study well these are available on the clinicaltrials.gov website we don't need to get into too much detail right now so here we are ready to go um and uh which herbs are we going to use what's our actual intervention now as dr chen had uh mentioned there was a he actually gave us a lecture around this time on the e-lotus platform provided a very clear overview of the treatment strategies based on the national treatment guidelines and primarily as he mentioned it's multiple formulas based on pattern diagnosis or stages of disease or there is a kind of a one-size-fits-all bitcoin dirty 21 herb formulation that's irres that can be used irrespective of who the patient is now we didn't take this slightly as a clinical trial when we were designing it as a clinical trial the prospect of having a single intervention is wildly preferred i mean it's almost impossible to have a randomized controlled trial certainly a blind and randomized control trial if you have multiple formulas on the other hand if this is our shot to try to show uh on the large stage how chinese medicine is practiced how comfortable are we at using a formula that is not the way that chinese medicine was practiced and it basically came down to whether or not which language are we speaking are we speaking chinese medicine are we speaking double-blind randomized controlled trial um this is really really challenging for us to figure out you know we we rapidly found out that we are not the right people to decide this what we did was we um we tapped into the greatest minds in chinese herbal medicine that we could find one of them i've had the pleasure of working with for several years dr lon cal i'd like to invite up to talk more about what we did in our next steps and more about the formula that we used thanking doc thank you very much dr shuboff for that um amazing presentation okay so my my talk will be focused on the chinese herbal medicine arm of the mach 19 trial and before i begin i'd like to say hello to everyone and thank you very much for the team at pacific college as well as lasa oms for their great work in organizing this event especially to dr john chen for bringing us all together to speak on the clinical trials so as a co-investigator on the team i play the role of the chinese herbal medicine medical monitor and it's it's a rather unique role because it's not often that you'll come across an rct with an herbal medicine medical monitor on the team so i hope this would be the first of many in the future and as dr shubhoff mentioned you know it we didn't rush into choosing um the formula that we did with um the qfpd and so as we draw we solicited um expertise i mean not only with clinicians in-house and researchers from the various uc's but also chinese medicine professionals in the community um but like like dr schubert mentioned by the end of march we had a study design that we had not chosen a formula so we consulted dr kakehui at the center as well as dr shulin ma and others um to help come up with a formula and so we we did we did come up with the the um we decided on uh chingpay by dutan but there was literally no information published about this formula and uh maybe just a couple of papers that dr weijinjang helped us locate in terms of potential side effects from the formula what we had was mainly information that was coming from the hospitals and reports clinically and so that's when we reached out to dr john chen and it was really extraordinary to have his help to help us establish some safety measures for using this formula as well as dr zev rosenberg who's kept us on track with maintain you know importance of pattern differentiation and dr willa liu and um helped us establish safety for each individual herbs chemically and dr hobbing was one of the few practitioners during this time that was using this formula with his patients so he was extremely helpful as well and i i just there are others who contributed to this uh and they're not here but um i do we really appreciate their input and the webinars that were presented during this time and like i said there was just very little information or anything published now when you go onto google and you do a pubmed search you'll find a lot of information on this qfpd but back then in march there was nothing really so um dr john chen referred to this text earlier so i'm not going to spend too much time on it but we were really fortunate that we had access to this clinical guidelines that was um produced by the chinese government but also you know the the the um the national administration for chinese medicine from the people of the republic of china and um and this was published on february 2020 and so this is one of the texts that we use as we continue to build the study and in this text what i didn't include in here that dr john chen mentioned earlier was the recovery stage but as you see on the right column excuse me the left column in clinical classifications so the new coronavirus was delineated into four case uh four types of cases mild general cases severe cases and in critical cases and and lastly recovery phase which um i believe chinese medicine could be and have enormous impact on as well but on the on the right column the authors of the text did give us some differentiation of the patterns however it's a bit more complex than than it seems so again we'll start with the medical observation phase when the the case is not confirmed um there are these formulas like horizontal and liam huaching when capsules when used but again we the when a person is confirmed uh to have covet the first line formula that was used is ching fei baidu tang which is appropriate for mild uh general as well as severe cases when used alone but it can also be used in critical cases and i've highlighted and read here the diagnosis that the differential patterns and diagnosis of the authors included in this text and it's not simply just um differentiation based on shanghai lin postulates there's also as you can see like under general cases the terms such as damp poison obstructing the lungs and under severe cases the terms such as lung blocked by epidemic toxins so surely this is not something that's um clearly um explained in sean hanlon but more uh bringing in the precepts of the wen elon so this is different from wen being the the win elon is the the treatise um that was developed by dr wu uh yoko in the ming dynasty during the 16th century and it talks about the treaties of epidemics and associated with how transmissions of plagues happen and particularly the difference another key difference is it talks about the incubation period of a virus and the the pathogen is entry is mainly through the nose and the mouth whereas in shanghai the the entry is through the skin and and hanlon deals with of course as many of us know invasion of external pathogen and mainly due to seasonal changes but with this type so here with kovic we're not just we're not just dealing with um we're not just doing with external pathogen this particular pathogen is a sort of an invisible type of pathogen that can affect old or young strong or weak anyone is susceptible to getting infected and so i what i did with these symptoms um just keep these symptoms in mind for later on in the presentation and how we were able to incorporate this into into this study and oh just another few comments about the form of chin fade by dutong so this formula is really effective for um when when there's multiple um pathogenic pathogens in in various parts of the body so it's appropriate to use but once the symptoms subside then the formula should be stopped and then it's also not appropriate to be used as a prevention however it is appropriate to be used in condition where we see symptoms in long covet cases so this is dr john goli in the right side he's 72 is a 72 year old physician that works in wuhan and is still there and he is the main developer of the formula and along with his colleagues on the left side there so by february of 2020 the chinese government as well as the tradition the administration of tcm they jointly recommended qfpd for um for the need for the use for the treatment of covet based on clinical efficacy and the vice president of the beijing university of traditional chinese medicine around this time noted as well the wide distribution of this formula throughout the province and also lastly i wanted to share like also during this time there was a field hospital that was established um for the kind of like the oh um for the overflow of patients to help out with the hospitals and most of these practitioners and doctors were chinese medicine doctors and there were about 560 plus patients and most of the patients recover i mean all of the patients recovered uh without getting into the um severe and critical stages and um no one actually there were no fatalities among in this group and more importantly the staff and the physician and practitioner no one got infected in this field hospital and recently dr wen shared with me just about three weeks ago there was also news from another hospitals of similar setup with 580 patients um and 90 of these patients were affected by the new delta variant and 90 have recovered and and so far there was no fatalities either so dr john chen mentioned this as well earlier about the chinese um composition of the chinese herb composition of chain fate by dutong and many of us were familiar with this formula uh these formulas so mashems and in addition the authors of this formulation they added four herbs so every herb that you see in each box are the herbs are included in the formula what they did what they left out was um is i i kept it in a black ink so wrenching dots out and weights were kept out of the formula so the additional herbs have their particular purposes together they address issues and all the three jowls middle excuse me upper middle and lower gels and it's very interesting because some of the clinical presentations that i've observed that my peers have observed and those who um with the delta variant is that these four additional herbs are very relevant and useful in dressing the the current presentations with a delta variant so again moshi and shirgan tong um is traditionally as we know in shanghai and addresses tai young symptoms and patterns as well as sugan xiao chai hutong it's uh it also has antiviral as far as as well as various cars anti-carcinogenic properties and and very importantly it helps promote lymph drainage so again you know when you learn the pathogen particularly we mentioned that the toxin the pestilence it attacks and tends to hide in the half interior have exterior areas of the body so for those of us you know familiar with sean hanlon we know that's a xiaoyong stage of disease where the disease is half in the anterior half an exterior but also within the body we're talking about like the interstitial spaces um such as the pericardium or um the um pleura so xiaoyu tong plays a really important role in in this formula and uh rulings on as well deals with um the need to kind of dispel the pathogen from the body and and that's one of the main tenants of the wing eat is that when there's a pestilence and toxins in the body the dispersing of the phlegm the dampness is very important in addition to the dispelling of the pathogen um and the additional herbs um you'll see on the brown uh box the additional herbs help to support and protect our gi functioning um for for those you um that have um that are going through this condition so it also has anti-diarrheal anti-anemic effects um and regulating upper middle lower jaws as well as i mentioned earlier so again as you can see you know qfpd is a complex formula of 21 herbs but perhaps it's the most appropriate or one of the more appropriate given the complex nature of covet 19. and i describe it as a multi-targeted formula not only so for instance with motion sure gone tongue you know we're not just the formula is not just addressing the lungs and respiratory issues but other again in these interstitial areas and help to prevent the um the overactive inflammatory response and sugar as well is good is very effective for the lungs and for asthmatic conditions inflammation tonsillitis or throat you can see there and again xiao chai hutong has such an important role um probably one of my favorite formulas in this list it you know it goes to the liver as well as having antiviral and assisting the lymph system for drainage and ruling sun also helps in the lower jaw of draining the pathogen from from the look from the interstitial space places and the additional herbs you know all the together they they go to the lungs the spleen stomach but as well as address addressing the large intestine so we know that you know co despite protein and cocaine attaches to the h2 receptors and so there's ace2 receptors not only in the lungs but also in the large intestine and the liver and currently there are two published articles on the mechanism of qfpd and how does it benefit um in face of covet 19 and there are three areas domains that they were able to identify and one is that it has anti-viral effects as well as anti-inflammatory and and also kind of regulation of these metabolic pathways where the virus it just um that the virus used to replicate itself so um this formula helps to direct disrupt these various pathways so we didn't use the um we let me correct that we tried to stay as true to the formula as possible to the original formula qf pd we did modify it though however and the reason why we modify is mainly for safety issues in addition to the fact that the study team were thinking well if you know if the study outcome was not favorable that modify qfpd would not negatively impact the original formula and lastly there was no intention on the study team for commercial commercialization of the um the modified um product so how are the safety issues addressed so this is when uh dr john chen was really instrumental in helping us establish the safety measures in the study we looked at every single herb the caution and contraindications of the 21 earth formula and especially their drug interactions and there were many many that we needed to take in consideration and any uh any particular drug even if it was cautioned for news we include that in the exclusion criteria and again three the most contentious or controversial herbs were not controversial but it was it was it was it was brought up a lot of discussion among our chinese medicine experts in the community as well as within the study team um so kung dong-hwa as dr john chen mentioned earlier because of the you know is a it has a pyro lysadeine um alkaloid it is a pyrolyzodine alkaloid and so it can create liver toxicity or potentially create hepatotoxic um situation as well as being carcinogenic and although we can use it in folks with liver disorders but it would be an extreme um extreme caution so we had to modify it and what we did not change um hong kong and shishin of course many of we know that mahwang is an ephedrine alkaloid and it's very stimulating particularly to the central nervous system and the cardiovascular nervous system and so those that are on anyone on medication that could interact uh um the medication could interact with mahon we just um we took that into consideration and we put in the exclusion criteria uh but we kept mah huang in uh just being very strict with uh who we include into the study and with shishin you know it has aristolocic acid and that um trace amounts of it so we wanted to keep this as well because um for the type of respiratory conditions of the lung issues that we were seeing sheen was really hard to to replace and so um we needed the sheeshing that we use in this study formulation um is not has non-detected uh levels of aristolotic acid according to the fda regulations and lastly the team included a chinese herbal medicine medical monitor which is the role i serve to oversee any adverse effects with the study medication and if uh there were any that were noted then that this would be advised to the medical monitors which is dr andrew schuboven and dan slater and you know i just want to make also make a note that there was a lot of discussion on whether or not to keep makwang or to substitute it and uh dr john bolling lee himself we were able to be in contact with his secretary and he gave us potential substitutions as well because the formula originally is used in wuhan which is very cold and damp and so we were concerned that with the drier arid environment in california how would that affect people's response to the formula and so uh substitutes such as shangru was was strongly recommended among our chinese medicine practitioners as well and first and also substitute shishing but at the end we we kept these herbs so that we can keep the formula as intact as possible and yet at the same time maintain safety for participants in the study so this is the inclusion criteria uh basically um yeah anyone of age of 18 or older is it can can enrolled um uh to can apply for um the study um proof of positive code coca-19 diagnosis and willing to limit alcohol and cannabis and dairy consumption originally we made this as a requirement but we were concerned that it would turn too many people away so we turned into a recommendation instead and then also um participants will be able to commute would need to be able to communicate with our study staff as well as write down their daily symptoms so for safety monitoring so these safety this exclusion criteria applies to all three studies um of the mach 19 study uh so any any yes answers to these questions in red would exclude um a person from being uh participating in the study and we recommended them to immediately seek their physicians of counsel um and in addition to the other side the exclusion criteria so because of the formula anyone taking other investigational drugs to treat code that were excluded from the study as well as anyone with liver disease renal disease uncontrolled hypertension so here is interesting because you're bringing back wong so um some will say well you know hypertension is contraindicated yes but the fda gave us a requirement like if the person has uh control hypertension they were eligible to to join participate in the study and and also pregnant and breastfeeding women were also excluded from the study we had additional exclusion criteria just for the herbal arm of the study and again this is due to the herb drug interaction that can possibly come up and so just to be safe we put on a list and so anyone taking any of these medications would be excluded from the study so this is my attempt to do some differentiation uh please forgive the busyness of this slide and and if this is my humble attempt i would say um this so again you know revisiting the four categories of covid as the authors describe mala cases ordinary cases severe case and critical cases so in the mild cases again we can see patterns of the taeyang from shanghai in there and in red is what the authors of clinical guidelines their diagnosis of the conditions so they kept cold damp obstructing the lungs and damp heat obstructing the lungs in the mild cases and when we get into the general cases of what's often seen with kovid um is that all three stages you can see symptoms from tai young young and xiaoyong in the general type of cases and um so moving it and there there is a the next block the blocks in red is for uh patterns that have rooted with warm exterior pathogenic invasions and so i the authors of the clinical guidelines they put this under the severe cases and um and yes i i put it in between because there's still fever and there's epidemic toxin but this is still treatable the severe cases [Music] also we'll see we'll continue to see fever even beyond the xiaoyang stage and irritability as well and we're also getting to the nutritive yin level as well how we understand the precepts and when being and thai we see start seeing patterns of taiyin and xiaoyin in these severe cases and again the red box the authors uh the guidelines describe this as flaring heat in the qi and yin level where we may see bleeding symptoms and potential convulsions and then the critical stage which most of us will what we would not be seeing on such patients uh but again internal block and outward assertion this is when ventilation would um would be needed for for patients under this very critical stages and so these symptoms so what i did was i took the symptoms that the authors in the clinical guidelines um mentioned in their text as well as the shanghai limb symptoms and as well as the when being as symptoms as well as the potential cautions and contraindication for the herbs in the 21 earth formula qfpd and i condensed it into this daily diary which participants are asked to fill out daily during their 14 study period 14-day study period and that was highlighted is the symptoms of cova and the rest are key symptoms that i felt would help us number one to help with safety monitoring and number two give us help us gather information for retrospective analysis of the data to see for instance which patterns were at higher risk for which patterns recovered better so even in the eighth edition of the clinical guidelines there the authors don't mention or give us a percentage of the various patterns are that are susceptible or are high risk and so this um patients are also this simple they rate their their symptoms according to our symptom scoring scale or zero through four um and lastly just a quick summary um before i turn the floor back to dr shubov and you know it's not just about the formula but the clinical implications and mainly like the chinese urban emotions can play an important role as a pandemic continues and cases of long covet increase um and if the study established safe um once hopefully the ones that study established safety this could potentially open doors for mohammed to legally be available for practitioner in the future and i hope this presentation will give you inspiration for advanced learning of the formulas and the trust and the classics to build our clinical acumen and lastly you know we'll we need your help to spread the word and recruit during this recruitment stage of the study and i'm going to turn this floor back to dr shubov hi again thank you very much dr cow um so uh yeah thank you for that for that um so we have a plan we have a formula we have a reason for it another little bit is that we have um uh we have we have a treat today after this talk we're going to have a q a with dr john chan and also dr zeb rosenberg who had uh a huge role to play in helping us determine this um and so uh we'll get to you know talk the group of us and so i want to actually i have quite a bit here to talk about about the regulatory burdens but i'm hurdles but i'm going to try to get through this relatively quickly so we can make sure that we have time for questions afterwards so these are the major categories of challenges that we had to deal with the first was the supply so having an idea of an herbal formula is just the first of um you know the rubber started hitting the road and we actually wanted to find out what we had to find out what we're actually giving to patients so we started to work with um with uh herbal suppliers and realized that the real challenges here so the first thing is that chiang pai pai do tongue is a herbal decoction you can't blind an herbal decoction you can't uh you know yeah there's no way to blind it and actually later on the fda told us not to use masking agents to change the color or the smell of things um so we need to use capsules and you can condense a decoction into granules and then put those granules into capsules but the best that we could condense was about seven to one which still ended up with 20 out the you know the formula is 200 grams and so if we condense it down to 28 grams that's still almost 60 capsules we determined we felt that the the maximum that we can expect a study participant to take would be eight capsules three times a day um which is only 12 grams out of 28 grams now to make matters worse once we started actually talking about this process we learned that we also needed about 50 filler in the capsule so that brings it back to 120 capsules a day it was this was a brick wall so as soon as we got going here was a brick wall again what to do we uh we're fortunate enough to work with sunten laboratories and and um they uh were downright philanthropic with their ability to tolerate us and our demands and our needs here um there was there are specialized techniques that we were that were available to us if we um brought it down to to allow us to bring the excipient which is the filler down to five to ten percent but that still led to a sub-optimal dose so again in other words we can deliver an equivalent of 74 grams out of to the 200 gram formula we again brought this to our panel of herbalists and generally speaking their answer their reactions were kind of you know grumbling and i guess this is this is counts as basically the minimum effective dose we would think but maybe we can extend the duration of treatment so um the typical duration is three to six days this is a 14 day this will be a 14 days duration you know these are the kinds of compromises that we didn't expect to have to make early on um and we were fortunate to have a lot of people to hang back on it looks like now actually there are other clinical trials that are using a similar kind of uh thing 14 days of of a lower encapsulated dose um now beyond this there was a lot more that was required of our supplier and again hats off to the team at sunten for working with us we needed to create a dedicated extract here on very short notice with all of the botanical raw materials available for testing we'll talk about the testing that's required in great detail in a minute um we'll also we also need some herbs that are very highly regulated xi shin it's very hard to come by it because it has um because of the the potential of orisaylocic acid which causes genera like genuine harm in patients so the shishin that's available has to have undetectable quantities of versalocic acid and be able to prove it uh based on mass spec and uh each of the other herbs had uh had to pass each of the other requirements now it's one thing for a company to state that their herbs can pass each of these strict requirements it's another thing for us to get several months into the process and then be counting on um these being passed so talking about the regulatory requirements that we need to do uh let's get into the tlas the three-letter acronyms we had to deal with the fda the irbs and the deas um one d dea now the fda of all the groups actually um somehow i maybe i'm a little bit uh excessively on social media but there seems to be some misinformation about the intentions of the fda and chinese medicine or the alternative medicine in general we worked very closely with them through this whole period and i can tell you for certain and i'm not paid to say this but they were there was not a hint of bias against chinese medicine and actually when when we came uh when we had a limit to the ability that we can meet their demands or their requirements they were just a little bit flexible enough when it counted in a way that made it clear that they wanted to see this and first of all we had to use the fda because this was not a botanical supplement this was a drug and then the drug is defined by its intention because we were intending to look at the rates of cobit hospitalization we are intending to use it as a drug to treat copin 19 and there is no way around this there's other ways of of not having to classify an herb as a drug that didn't apply to us we had to go through this whereas many clinical trials might not um if you want to submit an investigational new drug application these are the steps to do and this might help to explain our timeline here we begin the conversation with the appropriate fda representative you submit what's called a pre-ind so take a step back an ind application is what's required to classify an investigational new agent as a investigational drug and that gives you license under the fda to then submit it so we were able to submit it to the customs agency to have it imported to the irb to have it to be able to deliver it to patients so the ind is considered the ind application so you just use that for short we submit a pre-ind application which is kind of like our master's thesis for why we think this will be helpful they have 60 days to look through this with a fine tooth comb and then summon us to a meeting in washington dc in our case this was just a very stressful phone call and we got a favorable response where they they had some very very helpful although frustrating but not critical uh advice for us and genuinely all of their advice basically helped us make a better study they needed to make sure it was safe and it was going to be effective they added us they added some some recommendations to make sure it was good so they were like a strict teacher for us it was actually a very helpful relationship um at the same time we recognized that they were burning the midnight oil to try to get all these other things going at the same time so they were working quite hard during this time uh we submitted our final ind application in july and then if that's approved they have 30 days to approve it you get a study may proceed letter hopefully within 30 days if not approved the fda will issue a clinical hold and that's what happened to us because we at this time we had not completed manufacture of the mqfpd and so we could not actually submit the complete ind application until we had the complete uh drug manufactured and then submitted that for all the requisite testing and so that didn't happen until april and then the irb had to take another two months so that's why we just started uh in june of this year for this this section incidentally uh hats off to marlene barrow who's uh who's a person who works at the university of california through multiple centers she's an fda liaison without her none of this would or many other studies would have been possible um so anybody that's interested in botanical drug research needs to be aware of this document this is a a 2006 update to a 2004 document of the fda that basically outlines their uh requirements for botanical drug development and it's actually very much the same as their requirements for anything else except with the uh the additional i'll tell you a little bit more you know it'll become obvious but the first two components of this are chemical constituents and prior human experience and this is basically our master's thesis um and um uh uh this is basically based on on prior data uh so we don't have to go into this this would be where you had preclinical or lab data what really got us stuck is this chemistry manufacturing controls data so for each of the 21 herbs the fda requires that we have tests for elemental impurities microbial limits residual pesticides including parent pesticides aflatoxins foreign materials and adulterous so this is pretty well um step one this is step one uh i'll also pull this out because this is fascinating to me they also require that they determine whether a plant species is determined to be endangered threatened or entitled to protection or in a critical habitat that has been determined to be endangered or threatened this this to me is a crowning achievement to integrative medicine over the last 20 years that this is in the fda guidance documents for botanical drug research they consider their purview to be beyond safety of humans but to safety in the environment i i think this is very well intentioned um uh other things they so their next section botanical drug substance characterization this is interesting because each of the botanical drug each of the 21 herbs not only do they need a quantitative description of what this drug substance is is they need a qualitative description of the drug substance this is interesting because this differs from most pharmaceuticals which the qualitative description isn't so important but as we may know um in herbal medicine the qualitative description is is primarily how substance is described and then we have to talk about the manufacturing process which turned into a huge administrative delay because we needed non-disclosure agreements between multiple institutions it was a mess um and then finally we if we take our final product and we have to subjected to all these additional tests so again it was you know one thing to make all these um plans uh to make these tests and all these assurances that they're actually going to come up within limits and then uh it's quite a relief when they actually uh met those limits this is also i'm sorry i didn't mention uh ma huang then has to be uh characterized for ephedrine and pseudoephedrine content quantified uh she shen and um there were some other things that we got we're able to skirt there's a there's uh if you were actually developing a botanical drug the requirements are much higher in terms of you need to develop basically agriculture farm to take to capsule approach to make sure that year after year you have batch to match consistency and we were able to not do that precisely because we as dr cow said we have no intention for commercialization here this is an open source study this is for you guys to commercialize um andrew five minutes left thank you thank you um and so with that this has been approved for the single bash that we have uh and uh that really was the only way that with the saving grace for us to be able to actually meet this requirement um i'll just skip through some of this stuff then we got to move to the irb which is exists at every institution every clinical study has to go through an irb when you have multiple clinical centers then you can choose one of the irbs and typically the other ones will rely upon it if i if we had to do it over again we might have chosen the irb a little bit differently that's all i have to say about that and then the dea usually doesn't get involved in these things but had to because of the presence of ma huang which is a regulated substance it's not a scheduled substance it's a list one chemical that's class that's a classification used for uh precursor chemicals of illicit substances so amphetamines can be made using using uh ephedrine not wong really but ephedrine and that makes it a list one chemical but unfortunately nobody really deals with these uh and so it took several agents before i could find somebody that knew about it how to guide me in the right way we went on a you know bark up a rock tree to try to become an importer and then learn that you can just hire a licensed importer um which is a little costly but but much more much more straightforward so we had the fda approval we had the irb to well we're working with the irb and then we hit another grip wall is the political considerations this is not really so much the brick wall the next slide is but we um by the time the summer hit uh people sobered up a little bit there was um people returned to their normal routine they got hit by all sorts of you know lingering priorities that uh that suddenly came onto their desk and there was a change of priorities ucsf had to back out uci also had to back out a few months later la jolla immunology and cedars-sinai medical center these were groups that we were working with that also had to um had to back out but the big hurdle was the cova task force this now back to the spring of 2020 everybody wanted to help everybody wanted to have a clinical trial um anybody studying any supplement wanted to put this put theirs in and this clogged the system for um things that were prioritized by the uh by the uh by the institutions um priorities are generally uh predicted as uh things that are funded by the nih and things that are funded by the nih did not include chinese herbal medicine actually specifically the national institute of health did not want to look into therapeutics at this time so we were kind of stuck and we attempted to ask them well basically these koba task forces were set up to try to gate keep for re keep resources to make sure that the prioritized studies could continue and um we had troubles with both of them uh this led to several month delay frankly to um until we could find out how to go go around it uh and then ultimately um you know we tend to be the we happen to be the last people standing now uh a lot of that traffic is cleared up and now both copic task forces at both institutions have given us the green light to basically um work as we need to uh there were some other institutional resources that were that took a lot of work to try to figure out how to get mobile's phlebotomy to go to the right lab we needed a nasal swab so we needed to find uh labs within our institutions that would do those a research laboratory to work websites with legal teams external offenders all sorts of things so um and then once that all came through we had to you know import this and et cetera et cetera so this ended up being our timeline and this kind of explains why these things are now just coming out now um that as you'll see here in the beginning we worked very very quickly it was declared a pandemic march 11th we had our initial meeting march 26th we submitted our pre-ind on april 8th and then we're able to um uh sorry we are early early april two months later we were able to submit our ind right after they submitted us our pre-ind and then the mushrooms were actually approved pretty quickly and ape was until april until we were able to get everything else lifted for the chinese herb component and then took another two months for the irb to then us to move forward with that so here we are today with our current challenge of recruitment and um now the actual you know as it as the story went we finally get our approval june 5th this was the nader of uh coven 19. there was it was almost well there was a nice little window there unfortunately with the delta variant we now have an opportunity to begin recruitment again and we do ask for some of your help if you know of anybody um this is the uh yeah i'll just leave it here um these are uh phone numbers that you can call you can direct patients to call basically our requirements or that people live within la or san diego that's because we need a mobile phlebotomist to not only go to their place but also to send their blood to our labs um and blood cannot be sent you know it has to be delivered in person uh there's also nasal swabs that have to go to a different lab there's a whole logistical thing behind there and also our licenses only extend um to the area uh and yeah please feel free to contact us and thank you all for for listening i'd like to open this up to the q a um and uh invite dr john chen dr said rosenberg dr sachs and dr cao back up thank you so much everybody um just a measure of how fabulous this talk has been so far is that many of the questions people have asked you've already answered um but why don't we go ahead and start with zev since we haven't heard from him before and upset if you want to open your microphone and just tell us a little bit about your involvement in the development of this project okay i didn't prepare any remarks for this panel i thought it would just take questions but i'm glad to oblige um i would compare the situation that we've been working with to like the proverbial chinese dragon or the leviathan like a fire-breathing dragon of a study that submerged underneath the ocean waves for a period of time and then all of a sudden with the delta variant coming to the fore and the final approval in june of the study of going through all these hoops with the fda and ih et cetera it just burst out of the water again and opened its mouth and started breathing fire again so now we've got a nice fire breathing dragon in our hands you know i see gordon almost every week we always take long walks together and and have dinner together and he's kept me posting and everything that's been going on and um it was at the beginning back last spring when we really had no idea what was really going on it was really quite um wonderful to meet such a wonderful group of people from ucla who at the integrative health studies center there and start working with them and start putting ideas together and looking at research coming out of china and also looking at more classical traditional sources because one of the amazing things is that the chinese have a 2 000 year history of dealing with and working with epidemics and have developed a huge armamentarium of both herbal medicine and acupuncture moxibustion strategies for treating with these various types of epidemics so it gave us a really strong foundation to deal with it one of my own personal interests for the last several decades has been studying how the chinese handled these epidemics and the formulas and treatments that they came up with so it was a a real time possibility in learning how to apply some of this knowledge after years of study and teaching at pacific college specifically of shanghain and wenbing courses both of which i initiated at the san diego campus and then the new york campus and chicago campuses afterwards so that's my piece there is a question for everybody and i know it's kind of a large question um but for each of you if you had to start over again what if anything would you do differently in this process i i feel like i can answer that i mean there's um uh this was a uh yeah there's some tactical things that i don't know if anybody really was able to advise us on at the time so things like which irb to use if we can find something a little bit faster maybe potentially um uh we would have there's a lot i think we would have ended up with a very with the same formula the intention behind the formula was really uh dictated based on this was the best thing we had at the time and we didn't want to mess with something that was proven and um and our our goal you know if we couldn't do something that was and that was true to the spirit of chinese medicine in terms of pattern diagnosis we should at least keep true to the formula so i don't think we would have changed the the things that uh that are on top on on on the surface that are the biggest hurdles of xishin and uh um what i would have changed would have been um wow probably you know what actually would have been great was that if we would have had a a pre-made uh formula that is already uh manufactured somewhere and we could find a supplier that had each of the component herbs available in the same of the same batch and we could send that for testing um if that makes sense and that would have because we needed to do this all prospectively and it takes time to make an herbal formula to make us a dedicated batch of granules it took a long time and uh that probably would have shaped some time off of our off bus anybody else yeah um i'd say in the early days of this if i had it to do over again i would have uh listened to uh andrew schubov a little more closely when he was urging us to try and get our application into the irb as quickly as possible and i was trying to negotiate a whole team of people and you know multiple people's schedules and all that and maybe we dragged it on for a week or two longer than than we might have and it turns out that was probably critical timing because it was after we had submitted our application to the irb and they were ready pretty much almost ready to approve it i don't think the irb was so much the issue it was the covid uh clinical research trials task force that then while we were in process with the irb forced the hand of the irb to freeze our study which otherwise the irb would have approved and so um if it happened what the the task force was actually created while we were in the process of waiting for our application with the irb to uh to get through their process if we had just gotten it in a little bit earlier we might have been able to get our approval from the irb prior to the task force perhaps averted all the delays from them but anyway hindsight is you know uh 2020. i think for the profession i think this is a the study it's a big thing i think it's actually historic and i know john chen has been doing work like this for many many years and the ucla center but it really does i i don't like the term foot in the door so much as establish an actual study using chinese medicine protocols in the treatment of a major pandemic and i think that's huge and i think the implications of the study even though it's a humble study with a relatively small number of volunteers it's still going to be really long-term historic in terms of the chinese medical profession in the west any um talk about combining with acupuncture in future studies i'm certainly in favor of that i think it's a great idea and in china of course they have done that there's a maybe some of you on the panel know leo lee hong he has done work in china both with herbal medicine and using acupuncture in hospitals it's not easy needling in a hazmat suit and that's what he had to do with his team in one of the hospitals in wuhan at the height of the epidemic there but um it is possible and apparently a lot of the patients really responded well i don't know of any particular studies that were formally done i'm sure there must be something in chinese language nothing has come out in english at this point i think that perhaps application of acupuncture might be beneficial but i defer to my colleagues who are more learned in chinese medicine than i am might be beneficial not so much in the treatment of acute covid but maybe in long covert in people who are suffering from chronic disability from covid as part of a multi-faceted strategy it's a tenacious difficult condition loads of people are suffering from it but hopefully at that point they're no longer infectious and it would be safe to needle them but that probably will take a lot more than just acupuncture but that might be a very helpful modality in a multi-faceted setting there are actually many many studies that are that are either been done or ongoing in china so there are many studies that focus on treatment or covariating there are many studies that focus on uh long covert and it's not just herbal treatment there's actually a lot of studies on herbal treatment on acupuncture treatment also on um lifestyle you know so they do tai chi uh qigong and many others and specifically for long coven you know so there there is not a shortage of ideas as far as what to what to use to help these patients the difficult part is um i i don't think most tcm practitioners appreciate how long and how difficult it is to do a clinical study you know it takes years and years and it costs a lot of money so as much as we like to see more studies done in the us we have to be very selective in our battles you know pick the ones that will make the most difference and then go with that you know instead of doing everything all at the same time and very exciting that you all chose herbs that can be controversial because they're the ones that work so well so keeping somehow keeping it simple but also not keeping it easy um and on that note there was some confusion i think among the audience about the availability of mahwang in the united states some people felt like there was no availability um so john would you we'll be willing to address that a little bit and is some point in a no man's land because fda classifies everything as foo as dietary supplement or as drug and it specifically says that mahwang is not a food because we don't eat mahwang ephedra on daily basis also mafa doesn't supplement our diet so fda has shut down those two paths basically to uh protect the general public but if you read the original fda documentation they do leave a window for tcm practitioner and it says that maplong is not used in either of these fashion in traditional chinese medicine and therefore if you stick with the traditional chinese medicine means it is allowed so what that means is if the herb was imported as raw herb it is used as a decoction pursue it you know following a tcm practitioner's herbal prescription then you are allowed to use it so i do know that commonwealth in new york they do carry this herb they do dispense it as a decoction so that's perfectly fine but you're not going to find mahwang as in a capsule form at a retail center for weight loss because that is exactly what the fda wants to get rid of and that's exactly what it did i also think many suppliers were herbal suppliers in this in this country were very worried about liability issues after that runner who had the heart attack and died i remember going to health food stores and seeing pep up supplements right in the checkout line you know with ma huang in them and uh very irresponsibly done and i i blame some of the at least a a proportion of the nutraceutical industry for abusing our right to using that medicine so i think there's a lot of fear of making it available yes a commonwealth by prescription will make it available to a practitioner but it's not in any prepared products as far as i know at this point i think another thing practitioners may also want to double check is make sure they check their um insurance to make sure their malpractice insurance does cover the use of martha before they consider using it also i'd like to add to this dr khakit huey he wrote a response to the fda in 1999 regarding mahwang they asked for his opinion and one of the reasons he said it was banned is because it's not because of the practitioners as john pointed out is because it was um used as diversion to use as part of making methamphetamine but you know smoothing ma huang energy and that was the main reason you know um but ma hong using a decoction the dea has no issues with that neither this is fda as john pointed out uh we do have lots more questions um but i don't think we're going to get to them all because we do want to end on time um but i'll just tell you the subject of the questions unless in case anybody wants to comment on them we have a number of questions about timing like how do we provide timely administration of herbs when we're currently recruiting so do patients progress to severe or even recovered by the time you can treat them and what do we do if a patient goes critical during this the study are they removed okay so anybody want to come in let me do that quickly uh yeah we're recruiting within the first few days of a symptom onset where you have a strict limit of nine days but really ideally between three and seven days of onset of symptoms or uh um of a positive cova test and so we do want people to be symptomatic where we can help them not necessarily asymptomatic um uh routine screening or something like that yes if people are critically ill or become critically ill they stop the medication uh and we follow up with them afterwards so uh at that point we do not follow them into the hospital we do not they do not they they're done with us in terms of um uh uh they're on to the medical care um anybody want to have have anything they want to say about um dosing form some people had questions about why weren't we using decoctions or concentrates or various you know granules etc let me just speak really quickly about that is that we we have a limitation of the clinical trial um forces and a artificial uh uh hand that that binds us to having to have something that is blindable and of a lower dose than might be used clinically by you guys as practitioners um so we're doing the best that we can with the constructs the constraints that we have uh and so we should not the the intention here is to demonstrate some safety and some value um so that it could be widely used within the your best like the the best uh understanding of the practitioner i also want to point out that the japanese use of herbal medicine compo uses smaller significantly smaller doses and still gets strong effects and i think that having a longer period of taking the herbs and the cumulative effect of it will still show to be efficacious clinically that's my opinion so well as i said we do have more questions but luckily we'll hopefully have lots more opportunities to do more webinars i want to thank our speakers especially and thank la oms our co-host and all the folks at pacific college diego morales on our tech tonight thank you all for joining us and we look forward to seeing you next time thank you thank you thank you everyone so i hope to see you all soon in person in real time in los angeles or san diego

Channel: PacificCollege

Views: 1,821

Rating: 4.9607844 out of 5

Keywords: chinese herbs study, ucla chinese herbs for covid-19, covid-19, chinese medicine, pacific college, pacific college of health and science, john chen, dr john chen, andrew shubov, dr andrew shubov, lan kao, dr lan kao, chinese medicine covid-19 study, fda approved chinese herbs study, lhasa, lhasa oms, chinese herbs formula for covid, ucla, ucsd, pcom, ucla chinese herbs study

Id: mD1Izk94Q70

Length: 92min 32sec (5552 seconds)

Published: Mon Sep 13 2021