Chinese Herbal Medicine for COVID-19 - FDA Approved Clinical Trial!
This is a good news / bad news kind of post!
The bad news is that if this applies to you, you have been diagnosed with Covid-19 in the last 72 hours, or are within 9 days of symptom onset.
The good news is that if you choose to and meet the eligibility requirements, you can now receive high quality Chinese Herbal Medicine as part of a clinical trial being run out of UCLA and UCSD! The FDA has approved a clinical trial to test the safety and feasibility of a specific Chinese Medicine formula during Covid infections.
More specifically, a
“multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. “
The formula being tested is a modified Qing Fei Pai Du Tang, a combination of Classical Chinese formulas which gained widespread use in China starting in February 2020 - when the government began to utilize a combined Western Medicine and Traditional Herbal Medicine approach to supporting their Covid cases. Anecdotal evidence and a number of clinical studies in China have pointed towards very positive outcomes.
A dedicated team in the US, including Chinese herbalists, medical doctors, epidemiologists, acupuncturists and pharmacists began the FDA approval process for a clinical trial back in March 2020. It took until July 2021 to meet all the compliance requirements, but the study is now approved by the FDA and in progress.
If you are in the Los Angeles or San Diego areas and wish to take part in the study contact them at:
EMAIL - covid19trial@ucsd.edu
CALL - 858-249-6896
40% of my readers are American (with California leading the states in viewers!), so I hope that this may reach some of those in need. Click on links below for the link to the clinicaltrials.gov site and UCSD & UCLA’s information on the trials, or keep scrolling down for all the details…
And please share freely and widely!
Chinese Herbal Formula for COVID-19
a study on COVID-19
Summary
Eligibility
for people ages 18 years and up (full criteria)
Location at UCLA UCSD
Dates study started July 1, 2021estimated completion December 2022
Principal Investigator by Gordon Saxe (UCLA)
Description
SUMMARY
This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This the study aims to establish the safety and feasibility of the use of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate other therapeutics as well as the efficacy of mQFPD in a larger study population.
OFFICIAL TITLE
Multicenter Double Blind, Placebo Controlled RCT of Modified Qing Fei Pai Du Tang (mQFPD) for COVID-19
DETAILS
Study participants will be assigned to one of two groups, either placebo or mQFPD. Participants will be screened and consented remotely. Both groups will receive blood draws at days 1 and 14, and will be sent study medication directly to their home from the investigational pharmacy. Baseline and end-of-study laboratory draws will be done at home via mobile phlebotomy. Adverse events and symptoms scores will be monitored by entry into a daily diary along with regular phone calls with the study coordinators. At the end of the study, safety will be assessed by laboratory measures and adverse event reporting.
KEYWORDS
Covid19mQFPDorganic brown ricemodified Qing Fei Pei Du Tang
Eligibility
YOU CAN JOIN IF…
Open to people ages 18 years and up
Positive COVID-19 diagnosis within the prior 72 hours or within 9 days of symptom onset
Age 18 years and older
Women of childbearing potential must have a negative urine or serum hCG.
Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use contraception throughout the study period.
Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team
Willing to try to minimize alcohol, cannabis, and dairy products during the study period.
YOU CAN'T JOIN IF...
Any of the following symptoms which, according to the CDC, require hospitalization:
Trouble breathing
Persistent pain or pressure in the chest
New confusion or inability to arouse
Bluish lips or face
Current use of investigational agents to prevent or treat COVID-19
Known liver disease (ALT/AST >3x ULN or diagnosis of cirrhosis)
Known renal disease (eGFR < 60 ml/min) or acute nephritis.
Uncontrolled hypertension (SBP>140 or DBP>90 while on medications)
Allergy to tree nuts
Bleeding dyscrasia or on anticoagulation (aspirin and/or clopidogrel is allowed)
Pregnant or breastfeeding women
Use of Tolbutamide
. Use of systemic corticosteroids (hydrocortisone, cortisone, prednisolone, betamethasone, methylprednisolone, prednisone, dexamethasone). Inhaled budesonide is to be allowed.
. Use of digoxin
. Use of Oxacillin
. Use of Interferon
. Use of Vincristine
. Use of Cyclosporine
. Use of Amiodarone
. Patients with a past medical history of epilepsy
. Use of monoamine oxidase inhibitors (MAOI)
. Use of Methamphetamine within the prior 30 days
. Use of Cocaine within the prior 30 days
. Use of aminoglycosides, carbamazepine, flecainide, lithium, phenytoin, phenobarbital, rifampicin, theophylline and warfarin
Locations
University of California, Los Angeles accepting new patients
Los AngelesCalifornia90095United StatesUniversity of California, San Diego accepting new patients
San DiegoCalifornia92093United States
Lead Scientist at University of California Health
Gordon Saxe (UCLA)
Details
Status accepting new patients
Start Date July 1, 2021
Completion Date December 2022 (estimated)
Sponsor University of California, San Diego
ID NCT04939415
Phase Phase 1
Study Type Interventional
Last Updated August 23, 2021