MedTrace Logo

Green Tea Lozenges for the Management of Dry Mouth

NCT01647737 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-18

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

MighTeaFlow

4-6 times daily

DIETARY_SUPPLEMENT

Xylitol

4-6 times daily

Sponsors & Collaborators

Principal Investigators

  • Scott S De Rossi, DMD · GHSU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01647737 on ClinicalTrials.gov