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NCT01647737 · ClinicalTrials.gov registry record · Phase 1
Green Tea Lozenges for the Management of Dry Mouth
A Phase 1 study, sponsored by Augusta University.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01647737: Completed Phase 1 study, sponsored by Augusta University.
NCT01647737 is a Phase 1 study that has completed, run by Augusta University. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01647737, a Phase 1 study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia. The major component of this formulation is green tea extract with a defined composition of polyphenols. Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in green tea extract, having properties consistent with effects on cells of tissues that would be protective towards local inflammation.
Primary Outcome
Change in salivary flow in Xerostomic patients using Green tea lozenges
Interventions
- DIETARY_SUPPLEMENT MighTeaFlow
- DIETARY_SUPPLEMENT Xylitol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
What the finished NCT01647737 record still lists
NCT01647737 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which MighTeaFlow is the first listed.
NCT01647737 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01647737 about?
NCT01647737 is a clinical study titled "Green Tea Lozenges for the Management of Dry Mouth". The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia. The major component of this formulation is green tea extract with a defined composition of polyphenols. Epidemiological stud...
What is the current status of trial NCT01647737?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-03. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01647737?
The interventions under investigation include: MighTeaFlow (DIETARY_SUPPLEMENT), Xylitol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01647737?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01647737's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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