Chinese Herbal Medicine for COVID-19 - FDA Approved Clinical Trial!

Photo for your visual pleasure! Not part of the clinical trial, though the herbs in the trial ARE in capsule form.

Photo for your visual pleasure! Not part of the clinical trial, though the herbs in the trial ARE in capsule form.

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...

  1. Any of the following symptoms which, according to the CDC, require hospitalization:

  2. Trouble breathing

  3. Persistent pain or pressure in the chest

  4. New confusion or inability to arouse

  5. Bluish lips or face

  6. Current use of investigational agents to prevent or treat COVID-19

  7. Known liver disease (ALT/AST >3x ULN or diagnosis of cirrhosis)

  8. Known renal disease (eGFR < 60 ml/min) or acute nephritis.

  9. Uncontrolled hypertension (SBP>140 or DBP>90 while on medications)

  10. Allergy to tree nuts

  11. Bleeding dyscrasia or on anticoagulation (aspirin and/or clopidogrel is allowed)

  12. Pregnant or breastfeeding women

  13. Use of Tolbutamide

  14. . Use of systemic corticosteroids (hydrocortisone, cortisone, prednisolone, betamethasone, methylprednisolone, prednisone, dexamethasone). Inhaled budesonide is to be allowed.

  15. . Use of digoxin

  16. . Use of Oxacillin

  17. . Use of Interferon

  18. . Use of Vincristine

  19. . Use of Cyclosporine

  20. . Use of Amiodarone

  21. . Patients with a past medical history of epilepsy

  22. . Use of monoamine oxidase inhibitors (MAOI)

  23. . Use of Methamphetamine within the prior 30 days

  24. . Use of Cocaine within the prior 30 days

  25. . Use of aminoglycosides, carbamazepine, flecainide, lithium, phenytoin, phenobarbital, rifampicin, theophylline and warfarin

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Locations

  • University of California, Los Angeles accepting new patients
    Los AngelesCalifornia90095United States

  • University of California, San Diego accepting new patients
    San DiegoCalifornia92093United States

Lead Scientist at University of California Health

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

Image for your viewing pleasure only, not a part of the clinical trial information! Though the herbal medicine used in the trial IS in easy to take capsule form!

Image for your viewing pleasure only, not a part of the clinical trial information! Though the herbal medicine used in the trial IS in easy to take capsule form!

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