NCT01647737

Green Tea Lozenges for the Management of Dry Mouth

A Natural Formulation for Patients Diagnosed With Xerostomia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with subjective complaints of xerostomia will be given a screening questionnaire to complete. If they meet the criteria on this screening form, the research coordinator will be notified and will meet with the patient either immediately or at a scheduled follow-up appointment. The research coordinator will review the information and then explain the details of the study to the patient and obtain informed consent. Once the patient has signed the informed consent, the research coordinator will collect the demographic, medical history, and contact information from the patient. Any information missing will be noted for follow-up investigation by the research coordinator. If a subject is of child bearing age, they will be asked to complete a urine pregnancy test prior to enrollment.\[a\] First appointment -Screening, consent. \[b\]Follow appointments- review, then Patients will do VAS questionnaire, QOL questionnaire, Sialometry will be done measuring unstimulated whole saliva and Stimulated whole saliva for 5 min each.

Conditions

• Xerostomia
• Sjogren Syndrome
• Dry Mouth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MighTeaFlow	4-6 times daily
DIETARY_SUPPLEMENT	Xylitol	4-6 times daily

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-07-24
• Last updated: 2015-03-18
• Results posted: 2015-03-18

Locations

1 site across 1 country: United States