Trial Outcomes & Findings for Zinc and Green Tea Extract for Community Respiratory Viral Infections (NCT NCT04898023)
NCT ID: NCT04898023
Last Updated: 2025-03-07
Results Overview
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)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
7 days of follow-up
Results posted on
2025-03-07
Participant Flow
17 patients signed consent forms, but only 14 completed at least one study visit for which efficacy and safety endpoints could be assessed.
Participant milestones
| Measure |
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.
zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
|
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.
Placebo: Compounded capsules containing microcrystalline cellulose.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zinc and Green Tea Extract for Community Respiratory Viral Infections
Baseline characteristics by cohort
| Measure |
Zinc-green Tea Extract-ascorbic Acid
n=5 Participants
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.
zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
|
Placebo
n=9 Participants
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.
Placebo: Compounded capsules containing microcrystalline cellulose.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.4 years
n=5 Participants
|
23.6 years
n=7 Participants
|
21.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days of follow-upRecovery 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)
Outcome measures
| Measure |
Zinc-green Tea Extract-ascorbic Acid
n=5 Participants
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.
zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
|
Placebo
n=9 Participants
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.
Placebo: Compounded capsules containing microcrystalline cellulose.
|
|---|---|---|
|
Number of Patients Who Recovered From Cold and Flu-like Symptoms
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 7 days of follow-upAdverse 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
Outcome measures
| Measure |
Zinc-green Tea Extract-ascorbic Acid
n=5 Participants
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.
zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
|
Placebo
n=9 Participants
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.
Placebo: Compounded capsules containing microcrystalline cellulose.
|
|---|---|---|
|
Number of Patients With Self-reported Adverse Events
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 7 days of follow-upAbsence includes missed days from work or school and healthcare visits include hospitalization or physician office visit(s) for respiratory viral illness related complications
Outcome measures
| Measure |
Zinc-green Tea Extract-ascorbic Acid
n=5 Participants
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.
zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
|
Placebo
n=9 Participants
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.
Placebo: Compounded capsules containing microcrystalline cellulose.
|
|---|---|---|
|
Number of Patients Who Reported Days of Absence and/or Healthcare Visits
|
5 Participants
|
3 Participants
|
Adverse Events
Zinc-green Tea Extract-ascorbic Acid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zinc-green Tea Extract-ascorbic Acid
n=5 participants at risk
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.
zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
|
Placebo
n=9 participants at risk
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.
Placebo: Compounded capsules containing microcrystalline cellulose.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal upset
|
40.0%
2/5 • Number of events 2 • 7 days for each study subject
|
22.2%
2/9 • Number of events 2 • 7 days for each study subject
|
|
Skin and subcutaneous tissue disorders
Allergic Reaction
|
0.00%
0/5 • 7 days for each study subject
|
11.1%
1/9 • Number of events 1 • 7 days for each study subject
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place