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Mushroom-Based Natural Product for COVID-19 Vaccination (MACH19 Trial)

N/A

Waitlist Available

Led By Andrew Shubov, MD

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 180 days

Summary

This trial is testing if supplements made from two types of mushrooms can help people getting COVID-19 vaccines by boosting their immune response and reducing side effects.

Who is the study for?

This trial is for adults over 18 who are getting the COVID-19 vaccine and can track their health daily. Participants must not drink alcohol, use cannabis, or consume dairy during the study. People with kidney or liver diseases, as well as pregnant or breastfeeding women, cannot join.

What is being tested?

The trial tests if two mushrooms (Fomitopsis officinalis and Trametes versicolor) can boost the immune response to COVID-19 vaccines. It's a blind test where participants randomly get either the mushroom mix (FoTv) or a placebo without knowing which one they receive.

What are the potential side effects?

Potential side effects of FoTv aren't detailed here but could include typical reactions to supplements such as digestive discomfort, allergic reactions, or changes in energy levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alanine transaminase concentration

Albumine concentration

Aspartate transaminase concentration

+6 more

Secondary study objectives

Peripheral Blood Mononuclear Cell (PBMC) immune profiling

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MushroomsExperimental Treatment1 Intervention

Drug: FoTv The dosage of FoTv is 8 capsules three times a day for 4 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary. Should swallowing capsules be an issue, they can be opened and dispensed into water or juice for easy ingestion.

Group II: PlaceboPlacebo Group1 Intervention

Placebo: organic brown rice The dosage of Placebo is 8 capsules three times a day for 4 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary. Should swallowing capsules be an issue, they can be opened and dispensed into water or juice for easy ingestion.

Do I qualify?Apply below to find out