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Zinc and Green Tea Extract for Community Respiratory Viral Infections

Primary Purpose

Respiratory Viral Infection

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
zinc-green tea extract-ascorbic acid
Placebo
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Viral Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 18 years and older
  4. Ability to take oral medication and be willing to adhere to the prescribed dosing regimen
  5. Self-reported cold or flu symptoms for ≤ 36 hours

Exclusion Criteria:

  1. Pregnant or actively seeking to become pregnant
  2. Positive for influenza with planned treatment with oseltamivir or baloxavir
  3. Chronic liver disease
  4. Acute secondary bacterial infection at the time of enrollment
  5. Requiring hospitalization for any reason at the time of enrollment
  6. History of copper or iron deficiency
  7. Current prescription for quinolone antibiotics, tetracycline antibiotics, or penicillamine at the time of enrollment
  8. Allergy/intolerance to any of the active ingredients under investigation including zinc citrate, green tea, and ascorbic acid (vitamin C)
  9. Patients without decision making capacity

Sites / Locations

  • University of MissouriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

zinc-green tea extract-ascorbic acid

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of recovery from cold and flu-like symptoms
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
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
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

Full Information

First Posted
May 18, 2021
Last Updated
May 31, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04898023
Brief Title
Zinc and Green Tea Extract for Community Respiratory Viral Infections
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Viral Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
zinc-green tea extract-ascorbic acid
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
zinc-green tea extract-ascorbic acid
Intervention Description
Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Compounded capsules containing microcrystalline cellulose.
Primary Outcome Measure Information:
Title
Rate of recovery from cold and flu-like symptoms
Description
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)
Time Frame
7 days of follow-up
Secondary Outcome Measure Information:
Title
Rates of patient-reported adverse events
Description
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
Time Frame
7 days of follow-up
Title
Rates of patient-reported days of absence and/or healthcare visits
Description
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
Time Frame
7 days of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Camden, PharmD
Phone
573 771 7179
Email
camdenr@health.missouri.edu
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Camden
Email
camdenr@health.missouri.edu

12. IPD Sharing Statement

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Zinc and Green Tea Extract for Community Respiratory Viral Infections

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