Evaluation of Combination Zinc and Green Tea Extract Supplementation on Reduction in Symptom Duration and Severity Associated With Community Respiratory Viral Infections: a Randomized Control Trial (ZiPhenol Study)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Patients Who Recovered From Cold and Flu-like Symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 years and older
- •Ability to take oral medication and be willing to adhere to the prescribed dosing regimen
- •Self-reported cold or flu symptoms for < 72 hours
排除标准
- •Pregnant or actively seeking to become pregnant
- •Positive for influenza with planned treatment with oseltamivir or baloxavir
- •Current or planned treatment with an FDA regulated drug (including those under EUA) for COVID-19
- •Chronic liver disease (i.e. baseline liver function tests (LFTs) > 1.5x the upper limit of normal (ULN) or established cirrhosis
- •Chronic renal failure stage 4 or greater
- •History of kidney stones
- •Acute secondary bacterial infection at the time of enrollment
- •Requiring hospitalization for any reason at the time of enrollment
- •History of copper or iron deficiency
- •Current prescription for quinolone antibiotics, tetracycline antibiotics, or penicillamine at the time of enrollment
- •Allergy/intolerance to any of the active ingredients under investigation including zinc citrate, green tea, and ascorbic acid (vitamin C)
- •Patients without decision making capacity
- •Currently enrolled in another clinical trial for a respiratory viral infection
研究组 & 干预措施
zinc-green tea extract-ascorbic acid
Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment.
干预措施: zinc-green tea extract-ascorbic acid (Drug)
Placebo
Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients Who Recovered From Cold and Flu-like Symptoms
时间窗: 7 days of follow-up
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 score ranging from 0-absent to 3-very severe for each symptom assessed (max of 36 points possible; higher scores indicate a greater severity of symptoms)
次要结局
- Number of Patients With Self-reported Adverse Events(7 days of follow-up)
- Number of Patients Who Reported Days of Absence and/or Healthcare Visits(7 days of follow-up)
研究者
Syed Naqvi
Associate Chief Medical Officer
University of Missouri-Columbia