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Green Tea Lozenges for the Management of Dry Mouth

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Scott DeRossi, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01647737
First received: May 14, 2012
Last updated: March 17, 2015
Last verified: March 2015
Results First Received: January 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Xerostomia
Sjogren Syndrome
Dry Mouth
Interventions: Dietary Supplement: MighTeaFlow
Dietary Supplement: Xylitol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects had a diagnosis of Xerostomia

Reporting Groups
  Description
Green Tea Lozenge

GTP

Green tea lozenge: 4-6 times daily

Placebo Xylitol lozenge 4 - 6 times daily

Participant Flow:   Overall Study
    Green Tea Lozenge   Placebo
STARTED   30   30 
COMPLETED   26   25 
NOT COMPLETED   4   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Consented subjects diagnosed with Xerostomia and meeting all inclusion exclusion criteria

Reporting Groups
  Description
Green Tea Lozenge

GTP

Green tea lozenge: 4-6 times daily

Placebo

Xylitol

Green tea lozenge: 4-6 times daily

Total Total of all reporting groups

Baseline Measures
   Green Tea Lozenge   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   17   16   33 
>=65 years   13   14   27 
Gender 
[Units: Participants]
     
Female   30   29   59 
Male   0   1   1 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures

1.  Primary:   Change in Salivary Flow From Baseline   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: Sderossi@gru.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Scott DeRossi, Georgia Regents University
ClinicalTrials.gov Identifier: NCT01647737     History of Changes
Other Study ID Numbers: GHSU Lozenge Xerostomia Study
Study First Received: May 14, 2012
Results First Received: January 23, 2015
Last Updated: March 17, 2015
Health Authority: United States: Institutional Review Board