Trial Outcomes & Findings for Green Tea Lozenges for the Management of Dry Mouth (NCT NCT01647737)

Results Overview

Change in salivary flow in Xerostomic patients using Green tea lozenges

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

60 participants

Primary outcome timeframe

8 weeks

Results posted on

2015-03-18

Participant Flow

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

Subjects had a diagnosis of Xerostomia

Participant milestones

Participant milestones
Measure	Green Tea Lozenge GTP Green tea lozenge: 4-6 times daily	Placebo Xylitol lozenge 4 - 6 times daily
Overall Study STARTED	30	30
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Green Tea Lozenges for the Management of Dry Mouth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Green Tea Lozenge n=30 Participants GTP Green tea lozenge: 4-6 times daily	Placebo n=30 Participants Xylitol Green tea lozenge: 4-6 times daily	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants
Age, Categorical >=65 years	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Female	30 Participants n=93 Participants	29 Participants n=4 Participants	59 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	30 participants n=93 Participants	30 participants n=4 Participants	60 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Enrolled subjects completing 8 weeks of treatment

Change in salivary flow in Xerostomic patients using Green tea lozenges

Outcome measures

Outcome measures
Measure	Green Tea Lozenge n=26 Participants GTP Green tea lozenge: 4-6 times daily	Placebo n=27 Participants Xylitol lozenge 4 - 6 times daily
Change in Salivary Flow From Baseline Week 0	0.17 ml/min Standard Deviation 0.051	0.10 ml/min Standard Deviation 0.278
Change in Salivary Flow From Baseline Week 8	0.66 ml/min Standard Deviation 0.168	0.04 ml/min Standard Deviation 0.142

Adverse Events

MighTeaFlow

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Xylitol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MighTeaFlow n=30 participants at risk 4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks MighTeaFlow: 4-6 times daily	Xylitol n=30 participants at risk 4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks Xylitol: 4-6 times daily
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	3.3% 1/30 • Number of events 1 • Adverse event data was collected over a period of 27 months	6.7% 2/30 • Number of events 2 • Adverse event data was collected over a period of 27 months

Additional Information

Dr. Scot DeRossi, Chairman of the ORal Medicine & Diagnostic Sciences Department

Georgia Regents University

Phone: 706-721-2607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place