Phase 2
N=60
Green Tea Lozenges for the Management of Dry Mouth
Xerostomia · Sjogren Syndrome · Dry Mouth
Bottom Line
View on ClinicalTrials.gov: NCT01647737 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Change in Salivary Flow From Baseline — 0.17; 0.10; 0.66; 0.04 ml/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MighTeaFlow (Dietary_supplement); Xylitol (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Augusta University
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Salivary Flow From Baseline |
0.17; 0.10; 0.66; 0.04 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01647737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.