Green Tea Lozenges for the Management of Dry Mouth
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Rheumatology |
| Therapuetic Areas: | Rheumatology, Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/16/2015 |
| Start Date: | March 2011 |
| End Date: | March 2013 |
A Natural Formulation for Patients Diagnosed With Xerostomia
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.
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.
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.
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.
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
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