HOT TOPIC! COVID RESEARCH: MACH-19 | Mushrooms and Chinese Herbs for COVID-19
Top researchers at the University of California have launched a groundbreaking FDA-approved clinical trial to study natural medicine to fight COVID-19. In a recent live panel discussion hosted on , we had the opportunity to hear from the UCSD and UCLA investigators leading this pioneering study of mushrooms and Chinese herbs to treat COVID-19 outpatients confined to home quarantine.
The goal of the study is to test the safety, feasibility, and efficacy of a modified herbal formula (along with medicinal mushrooms) in a multi-center double-blind randomized controlled trial. Investigators’ creativity in overcoming regulatory body concerns while developing the study led to what could be a map for increasing approval for future research in Chinese herbal medicine.
Dosing and Safety Solutions
Since double-blinding can be challenging with decoctions and granules, the modified herbal formula was dosed in a capsule form. Due to logistics the most effective dosing could not be delivered in a 3-6-day prescription plan, so the study required smaller daily doses over 14 days.
Rather than shying away from herbs in the 21-ingredient herbal formula that raised concerns or were controversial, but which are traditionally most effective, like MaHuang/Ephedra and Xin (due to concern about aristolochic acid content), study developers decided to focus first on establishing the herbs and formula safety.
They bravely chose to keep the herbal formula (modified Qing Fei Pai Du San) as intact as possible while maintaining the safety of the patients through both patient exclusion criteria, as well as screening of herbs for toxicity. Investigators pointed out that the study, if it establishes safety, could help increase the legal availability in the U.S. of herbs like Ma Huang and XiXin, which are safe when used properly by licensed professionals.
Practitioner concerns about using one formula rather than individualizing treatments based on a holistic assessment of each patient were allayed by the webinar panelists. It is traditional to evaluate each case in Chinese herbal medicine and tailor herbal formulas for each patient as a result. In the treatment of large numbers of patients, however, research and regulatory bodies are necessarily interested in establishing the safety and efficacy of treatments that can be readily scaled for large numbers of patients. Study designers have designed symptom questionnaires for patients, nonetheless, that will allow them to evaluate results with Chinese medicine pattern differentiation in mind. The hope is that the data gathered about responses to treatment, along with patterns of symptoms and blood test results, will fuel interest in a next phase of trials that could address pattern differentiation more directly.
FDA Approval Process
Dr. Andrew Shubov, the lead investigator, shared that he was pleased to see that, during their FDA-approval process, there did not seem to be any bias against Chinese medicine or integrative medicine as a whole in comparison to Western medicine. In fact, the FDA made it clear that they were interested in seeing this study come to fruition. Dr. Shubov noted that the FDA’s approval process seemed much like a “strict teacher” guiding them towards a better approach to their study’s design and execution.
It is important to note that, because the team was including at least one ingredient recognized as a drug rather than a supplement (which is how most Chinese herbs are categorized), they were required to submit an IND (Investigational New Drug) application and get approval of the DEA (Drug Enforcement Agency) in addition to the FDA. Botanical drug development requirements involve chemistry, manufacturing, and control data; determination of whether the plant species is endangered, threatened, or entitled to protection; qualitative and quantitative descriptions of each herbal ingredient; and so on. The road to FDA approval was not easy! A much-celebrated approval for the study was granted on June 5, 2020.
The Next Challenge for MACH-19Â
Gathering recruitment for study participation is the next priority. Participants do need to live in the Los Angeles or San Diego areas, as phlebotomists need to be able to visit their homes to draw blood samples and return them to labs in a timely fashion. If you’re interested in participating in the study, click to visit the dedicated page on UCSD’s Krupp Center for Integrative Research website.
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Resources
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