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Green Tea Lozenges for the Management of Dry Mouth

Primary Purpose

Xerostomia, Sjogren Syndrome, Dry Mouth

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MighTeaFlow

Xylitol

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Sjogren syndrome, dry mouth

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS)
Clinical Diagnosis of primary or secondary Sjogren's syndrome.
Over the age of 18.
Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction.
Willing to use natural novel topical dry mouth products.
Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia work-up.
Willing to return for all study-associated visits.
Able to read, understand, and sign the informed consent.

Exclusion Criteria:

Have received radiation to the head and neck region.
Unable to read and understand the consent form.
On greater than three drugs associated with xerostomia or salivary gland hypofunction.
Require dento-alveolar surgery or extensive dental treatment during the course of the study.
Require hospitalization for any medical problem during the course of the study.
Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or xylitol because of allergy
Uncontrolled medical conditions that require changes in medication during the course of the study.
Regularly consume green tea and/or components of pilocarpus jaborandi.
Are pregnant

Sites / Locations

GHSU Center for Oral Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

MighTeaFlow

Xylitol

Arm Description

4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks

4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks

Outcomes

Primary Outcome Measures

Change in Salivary Flow From Baseline

Change in salivary flow in Xerostomic patients using Green tea lozenges

Secondary Outcome Measures

Full Information

NCT ID

NCT01647737

First Posted

May 14, 2012

Last Updated

March 17, 2015

Sponsor

Augusta University

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01647737

Brief Title

Green Tea Lozenges for the Management of Dry Mouth

Official Title

A Natural Formulation for Patients Diagnosed With Xerostomia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Augusta University

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xerostomia, Sjogren Syndrome, Dry Mouth

Keywords

Xerostomia, Sjogren syndrome, dry mouth

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MighTeaFlow

Arm Type

Active Comparator

Arm Description

4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks

Arm Title

Xylitol

Arm Type

Active Comparator

Arm Description

4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

MighTeaFlow

Other Intervention Name(s)

Green Tea Lozenge

Intervention Description

4-6 times daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Xylitol

Other Intervention Name(s)

Aspartame

Intervention Description

4-6 times daily

Primary Outcome Measure Information:

Title

Change in Salivary Flow From Baseline

Description

Change in salivary flow in Xerostomic patients using Green tea lozenges

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS) Clinical Diagnosis of primary or secondary Sjogren's syndrome. Over the age of 18. Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction. Willing to use natural novel topical dry mouth products. Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia work-up. Willing to return for all study-associated visits. Able to read, understand, and sign the informed consent. Exclusion Criteria: Have received radiation to the head and neck region. Unable to read and understand the consent form. On greater than three drugs associated with xerostomia or salivary gland hypofunction. Require dento-alveolar surgery or extensive dental treatment during the course of the study. Require hospitalization for any medical problem during the course of the study. Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or xylitol because of allergy Uncontrolled medical conditions that require changes in medication during the course of the study. Regularly consume green tea and/or components of pilocarpus jaborandi. Are pregnant

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott S De Rossi, DMD

Organizational Affiliation

GHSU

Official's Role

Principal Investigator

Facility Information:

Facility Name

GHSU Center for Oral Medicine

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25240992

Citation

De Rossi SS, Thoppay J, Dickinson DP, Looney S, Stuart M, Ogbureke KU, Hsu S. A phase II clinical trial of a natural formulation containing tea catechins for xerostomia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Oct;118(4):447-454.e3. doi: 10.1016/j.oooo.2014.06.015. Epub 2014 Jul 5.

Results Reference

derived

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Green Tea Lozenges for the Management of Dry Mouth

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