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Green Tea Lozenges for the Management of Dry Mouth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01647737
Recruitment Status : Completed
First Posted : July 24, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Scott DeRossi, Augusta University

Tracking Information
First Submitted Date  ICMJE May 14, 2012
First Posted Date  ICMJE July 24, 2012
Results First Submitted Date  ICMJE January 23, 2015
Results First Posted Date  ICMJE March 18, 2015
Last Update Posted Date March 18, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2015)
Change in Salivary Flow From Baseline [ Time Frame: 8 weeks ]
Change in salivary flow in Xerostomic patients using Green tea lozenges
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
Improvement in salivary flow from baseline [ Time Frame: 8 weeks ]
Improvement in salivary flow in Xerostomic patients using Green tea lozenges
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Green Tea Lozenges for the Management of Dry Mouth
Official Title  ICMJE A Natural Formulation for Patients Diagnosed With Xerostomia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Xerostomia
  • Sjogren Syndrome
  • Dry Mouth
Intervention  ICMJE
  • Dietary Supplement: MighTeaFlow
    4-6 times daily
    Other Name: Green Tea Lozenge
  • Dietary Supplement: Xylitol
    4-6 times daily
    Other Name: Aspartame
Study Arms  ICMJE
  • Active Comparator: MighTeaFlow
    4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks
    Intervention: Dietary Supplement: MighTeaFlow
  • Active Comparator: Xylitol
    4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks
    Intervention: Dietary Supplement: Xylitol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01647737
Other Study ID Numbers  ICMJE GHSU Lozenge Xerostomia Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott DeRossi, Augusta University
Study Sponsor  ICMJE Augusta University
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Scott S De Rossi, DMD GHSU
PRS Account Augusta University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP