Clinical trial NCT01647737: Green Tea Lozenges for the Management of Dry Mouth
Official title: A Natural Formulation for Patients Diagnosed With Xerostomia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Xerostomia
Sjogren Syndrome
Dry Mouth
Keywords: Xerostomia
Sjogren syndrome
dry mouth
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Salivary Flow From Baseline
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: GHSU Center for Oral Medicine
state: Georgia
Study officials:
affiliation: GHSU
name: Scott S De Rossi, DMD
role: PRINCIPAL_INVESTIGATOR
References:
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.