Respiratory Viral InfectionPhase 2NCT04898023
Zinc and Green Tea Extract for Community Respiratory Viral Infections
A Phase 2 study testing zinc-green tea extract-ascorbic acid in people with Respiratory Viral Infection, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Viral Infection
- What is being tested?
- zinc-green tea extract-ascorbic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 20 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Respiratory Viral Infection
- Being tested
- zinc-green tea extract-ascorbic acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc-green tea extract-ascorbic acidDrug
Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
PlaceboDrug
Compounded capsules containing microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| zinc-green tea extract-ascorbic acid | Experimental | 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. Receives: Drug: zinc-green tea extract-ascorbic acid |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Recovered From Cold and Flu-like Symptoms
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)
Measured: 7 days of follow-up
Secondary outcomes (2)
Number of Patients With Self-reported Adverse Events
Adverse events 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
Measured: 7 days of follow-up
Number of Patients Who Reported Days of Absence and/or Healthcare Visits
Absence includes missed days from work or school and healthcare visits include hospitalization or physician office visit(s) for respiratory viral illness related complications
Measured: 7 days of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start21 Sep 2022
- Primary completion31 Oct 2023
- Study completion20 Dec 2023
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Viral InfectionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Naqvi, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898023
- Sponsor's protocol ID
- 2035652
- Status last verified
- Feb 2025
- First submitted
- 18 May 2021
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04898023
- Acronym / sponsor ID
- 2035652
- Conditions
- Respiratory Viral Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc-green tea extract-ascorbic acid | Experimental | Drug: zinc-green tea extract-ascorbic acidRandomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. |
| Placebo | Placebo comparator | Drug: PlaceboRandomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc-green tea extract-ascorbic acidCompounded capsules containing each zinc citrate, green tea extract, and ascorbic acid. | Drug | zinc-green tea extract-ascorbic acid |
| PlaceboCompounded capsules containing microcrystalline cellulose. | Drug | Placebo |
Primary outcome
Number of Patients Who Recovered From Cold and Flu-like Symptoms
Time frame: 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)
2 secondary outcomes
Number of Patients With Self-reported Adverse Events
Time frame: 7 days of follow-up
Number of Patients Who Reported Days of Absence and/or Healthcare Visits
Time frame: 7 days of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zinc-green tea extract-ascorbic acid in people with Respiratory Viral Infection, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Recovered From Cold and Flu-like Symptoms (time frame: 7 days of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.