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Herbal Medicine
Chinese Herbal Medicine for COVID-19 (MACH19 Trial)
Phase 1
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Summary
This trial will study a herbal treatment for COVID-19 to see if it is safe and effective.
Who is the study for?
Adults over 18 with a recent COVID-19 diagnosis, not severe enough for hospitalization. Participants must be able to track and report their health daily, avoid certain substances like alcohol and dairy, and use contraception if applicable. Those with drug abuse history, severe symptoms or specific medical conditions like kidney disease, uncontrolled hypertension or liver disease are excluded.
What is being tested?
The trial is testing the safety of a Chinese herbal formula called modified Qing Fei Pai Du Tang (mQFPD) against placebo in treating mild-to-moderate COVID-19 at home. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment.
What are the potential side effects?
Potential side effects aren't specified but could include typical reactions to herbal supplements such as digestive discomfort or allergic reactions. Close monitoring will help identify any unexpected side effects due to mQFPD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of the intervention
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
C-reactive protein
D-dimer
Duration of viral illness
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: modified Qing Fei Pei Du TangExperimental Treatment1 Intervention
encapsulated modified Qing Fei Pai Du Tang
Group II: PlaceboPlacebo Group1 Intervention
Organic brown rice
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,178 Previous Clinical Trials
1,574,926 Total Patients Enrolled
Gordon Saxe, MDStudy Chair - University of California, Los Angeles
Regents of the University of California - UCSD Medical Group, UCSD Medical Center-Hillcrest
Michigan State University College Of Human Medicine (Medical School)
University Of Ma Medical Sch (Residency)
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You tested positive for COVID-19 in the last 72 hours or have had symptoms for less than 9 days.You have used cocaine in the last 30 days.You have used methamphetamine in the last 30 days.If you have any of these symptoms and need to go to the hospital: trouble breathing, chest pain, confusion, or blue lips.You are allergic to tree nuts.You are taking monoamine oxidase inhibitors (MAOI).You are currently taking experimental drugs to prevent or treat COVID-19.You have kidney disease or acute nephritis.You are taking certain medications like prednisone or dexamethasone, but inhaled budesonide is okay.Taking digoxin medication.You are currently taking Oxacillin.You have a history of epilepsy.Your blood pressure is not well controlled, even with medication.You have a bleeding disorder or are taking blood thinners, except for aspirin or clopidogrel.Taking Amiodarone medication.Taking TolbutamideYou are currently using interferon.You are currently taking Vincristine.You are currently taking cyclosporine.Women who could become pregnant must have a negative pregnancy test.You have liver disease with high levels of certain liver enzymes or a diagnosis of cirrhosis.You are currently taking certain medications like aminoglycosides, carbamazepine, flecainide, lithium, phenytoin, phenobarbital, rifampicin, theophylline, or warfarin.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: modified Qing Fei Pei Du Tang
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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