Green Tea Lozenges for the Management of Dry Mouth

Xerostomia Clinical Trial

Official title:

A Natural Formulation for Patients Diagnosed With Xerostomia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647737
• Other study ID #: GHSU Lozenge Xerostomia Study
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 14, 2012
• Last updated: March 17, 2015
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2015
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS)

2. Clinical Diagnosis of primary or secondary Sjogren's syndrome.

3. Over the age of 18.

4. Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction.

5. Willing to use natural novel topical dry mouth products.

6. Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia work-up.

7. Willing to return for all study-associated visits.

8. Able to read, understand, and sign the informed consent.

Exclusion Criteria:

1. Have received radiation to the head and neck region.

2. Unable to read and understand the consent form.

3. On greater than three drugs associated with xerostomia or salivary gland hypofunction.

4. Require dento-alveolar surgery or extensive dental treatment during the course of the study.

5. Require hospitalization for any medical problem during the course of the study.

6. Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or xylitol because of allergy

7. Uncontrolled medical conditions that require changes in medication during the course of the study.

8. Regularly consume green tea and/or components of pilocarpus jaborandi.

9. Are pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Mouth
• Sjogren Syndrome
• Sjogren's Syndrome
• Xerostomia

Intervention

Dietary Supplement:
• MighTeaFlow
4-6 times daily
• Xylitol
4-6 times daily

Locations

Country	Name	City	State
United States	GHSU Center for Oral Medicine	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Regents University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Salivary Flow From Baseline	Change in salivary flow in Xerostomic patients using Green tea lozenges	8 weeks	No