Trial Outcomes & Findings for Effect of Korean Red Ginseng (KRG) on Dry Mouth (NCT NCT00911768)

Results Overview

Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

8 weeks

Results posted on

2009-08-06

Participant Flow

Patients were recruited from the waiting room and consulting room of Oriental Clinic of Gastrointestinal diseases and Chronic fatigue of Kyung Hee East-West Neo-Medical Center (Seoul, Korea) between September 2007 and February 2008

Totally, 133 participants were enrolled in the trial; 100 participants screened and 33 of them (women 18, men 15) were excluded because of abnormal liver function (1), present illness (2), a plan to pregnancy (1), and self refusals or disconnections (28).

Participant milestones

Participant milestones
Measure	Korean Red Ginseng Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.	Placebo Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Overall Study STARTED	50	50
Overall Study COMPLETED	44	46
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Korean Red Ginseng Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.	Placebo Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Overall Study Protocol Violation	5	4
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Effect of Korean Red Ginseng (KRG) on Dry Mouth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Korean Red Ginseng n=50 Participants Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.	Placebo n=50 Participants Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	45 Participants n=7 Participants	89.0 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11.0 Participants n=5 Participants
Age Continuous	48.14 years STANDARD_DEVIATION 15.97 • n=5 Participants	46.02 years STANDARD_DEVIATION 16.14 • n=7 Participants	47.1 years STANDARD_DEVIATION 16.0 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	26 Participants n=7 Participants	54.0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	24 Participants n=7 Participants	46.0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	50 participants n=5 Participants	50 participants n=7 Participants	100.0 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Because primay outcome of the study was changes of Visual Analogue Scale of Subjective Dry Mouth between 0, 4 and 8 weeks, per protocol analysis was applied.

Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=44 Participants Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.	Placebo n=46 Participants Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Visual Analogue Scale of Subjective Dry Mouth	5.21 cm Standard Deviation 2.02	5.03 cm Standard Deviation 1.93

SECONDARY outcome

Timeframe: 8 weeks

Population: Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.

Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=44 Participants Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.	Placebo n=46 Participants Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Stimulated Salivary Flow Rates	1.046 ml/min Standard Deviation 0.552	1.392 ml/min Standard Deviation 0.549

SECONDARY outcome

Timeframe: 8 weeks

Population: Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.

Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=44 Participants Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.	Placebo n=46 Participants Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Unstimulated Salivary Flow Rates	0.220 ml/min Standard Deviation 0.153	0.266 ml/min Standard Deviation 0.185

Adverse Events

Korean Red Ginseng

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jae-Woo Park, KMD, PhD

Kyung Hee East-West Neo Medical Center

Phone: +082-02-440-6219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place