CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
MighTeaFlow +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01647737
NCT01647737Phase 2Completed

A Natural Formulation for Patients Diagnosed With Xerostomia

Augusta University·interventional·Posted Jul 24, 2012·Updated Mar 18, 2015

In Brief

A Phase 2 clinical trial evaluating MighTeaFlow and Xylitol for Xerostomia and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2012
Enrollment StartMar 1, 2011
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.9 years ago

Interventions

MighTeaFlowdietary

4-6 times daily

Xylitoldietary

4-6 times daily