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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 is a Phase 1 study that has completed, run by Augusta University. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01647737
The ClinicalTrials.gov registry entry for NCT01647737 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MighTeaFlow is the first listed.
NCT01647737 reports 0 study locations.
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.
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