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Green Tea Lozenges for the Management of Dry Mouth

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Xerostomia
Sjogren Syndrome
Dry Mouth
Interventions Dietary Supplement: MighTeaFlow
Dietary Supplement: Xylitol
Enrollment 60

Recruitment Details Potential candidates were identified from a pool of previously diagnosed subjects and new subjects referred to the Clinical Center for Oral Medicine, School of Dentistry, Georgia Regents University
Pre-assignment Details Subjects had a diagnosis of Xerostomia
Arm/Group Title Green Tea Lozenge Placebo
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GTP

Green tea lozenge: 4-6 times daily

Xylitol lozenge 4 - 6 times daily
Period Title: Overall Study
Started 30 30
Completed 26 25
Not Completed 4 5
Arm/Group Title Green Tea Lozenge Placebo Total
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GTP

Green tea lozenge: 4-6 times daily

Xylitol

Green tea lozenge: 4-6 times daily

Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
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Consented subjects diagnosed with Xerostomia and meeting all inclusion exclusion criteria
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  56.7%
16
  53.3%
33
  55.0%
>=65 years
13
  43.3%
14
  46.7%
27
  45.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
30
 100.0%
29
  96.7%
59
  98.3%
Male
0
   0.0%
1
   3.3%
1
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Change in Salivary Flow From Baseline
Hide Description Change in salivary flow in Xerostomic patients using Green tea lozenges
Time Frame 8 weeks
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Hide Analysis Population Description
Enrolled subjects completing 8 weeks of treatment
Arm/Group Title Green Tea Lozenge Placebo
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GTP

Green tea lozenge: 4-6 times daily

Xylitol lozenge 4 - 6 times daily
Overall Number of Participants Analyzed 26 27
Mean (Standard Deviation)
Unit of Measure: ml/min
Week 0 0.17  (0.051) 0.10  (0.278)
Week 8 0.66  (0.168) 0.04  (0.142)
Time Frame Adverse event data was collected over a period of 27 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MighTeaFlow Xylitol
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4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks

MighTeaFlow: 4-6 times daily

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

Xylitol: 4-6 times daily

All-Cause Mortality
MighTeaFlow Xylitol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MighTeaFlow Xylitol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MighTeaFlow Xylitol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      2/30 (6.67%)    
Respiratory, thoracic and mediastinal disorders     
Allergic Rhinitis * [1]  1/30 (3.33%)  1 2/30 (6.67%)  2
*
Indicates events were collected by non-systematic assessment
[1]
itching and scratchiness in the throat
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Scot DeRossi, Chairman of the ORal Medicine & Diagnostic Sciences Department
Organization: Georgia Regents University
Phone: 706-721-2607
Responsible Party: Scott DeRossi, Augusta University
ClinicalTrials.gov Identifier: NCT01647737     History of Changes
Other Study ID Numbers: GHSU Lozenge Xerostomia Study
First Submitted: May 14, 2012
First Posted: July 24, 2012
Results First Submitted: January 23, 2015
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015