Zinc and Green Tea Extract for Community Respiratory Viral Infections
Study Details
Study Description
Brief Summary
Zinc and green tea supplementation have both been independently studied for supporting immune health during cold and flu-like illness in non-hospitalized patients with clinical trials demonstrating promising but inconsistent results. Combination therapy may offer an improved effect as the antioxidant compounds found in green tea have been shown to increase cellular zinc concentrations thereby inhibiting viral replication. This study seeks to evaluate the effect of combination supplementation using established doses of zinc and green tea extract on symptom duration and severity from cold and flu-like illness, including COVID-19, in adult community patients enrolled in a randomized placebo-controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: zinc-green tea extract-ascorbic acid Compounded capsules will be prepared containing each 50mg of zinc citrate, 400mg of green tea extract, and 100mg of ascorbic acid. Randomized patients will take two (2) capsules taken orally two (2) hours following a meal twice daily x5 days. |
Drug: zinc-green tea extract-ascorbic acid
Compounded capsules
|
| Placebo Comparator: Placebo Compounded capsules will be prepared containing each 650mg of microcrystalline cellulose. Randomized patients will take two (2) capsules taken orally two (2) hours following a meal twice daily x5 days |
Drug: zinc-green tea extract-ascorbic acid
Compounded capsules
|
Outcome Measures
Primary Outcome Measures
- Rate of recovery from cold and flu-like symptoms [7 days of follow-up]
Rate of recovery is defined as achieving a daily total symptom severity score of 0 or 1 within 7 days using an established 12 symptom scoring system with a severity scale ranging from 0-absent to 3-very severe for each symptom (max of 36 points)
Secondary Outcome Measures
- Rates of patient-reported adverse events [7 days of follow-up]
Adverse events to be collected include: nausea, vomiting, indigestion, worsening of shortness of breath or difficulty breathing, allergic reaction including skin rash, and need to seek medical care (e.g. hospitalization or physician visit) for a suspected study drug related adverse effect
- Rates of patient-reported days of absence and/or healthcare visits [7 days of follow-up]
Absence will include missed days from work or school and healthcare visits will include hospitalization or physician office visit(s) for respiratory viral illness related complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of signed and dated informed consent form
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Stated willingness to comply with all study procedures and availability for the duration of the study
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Male or female, aged 18 years and older
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Ability to take oral medication and be willing to adhere to the prescribed dosing regimen
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Self-reported cold or flu symptoms for ≤ 36 hours
Exclusion Criteria:
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Pregnant or actively seeking to become pregnant
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Positive for influenza with planned treatment with oseltamivir or baloxavir
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Chronic liver disease
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Acute secondary bacterial infection at the time of enrollment
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Requiring hospitalization for any reason at the time of enrollment
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History of copper or iron deficiency
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Current prescription for quinolone antibiotics, tetracycline antibiotics, or penicillamine at the time of enrollment
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Allergy/intolerance to any of the active ingredients under investigation including zinc citrate, green tea, and ascorbic acid (vitamin C)
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Patients without decision making capacity
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Missouri-Columbia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2035652