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Trial record 13 of 712 for:    dry mouth

Effect of Korean Red Ginseng (KRG) on Dry Mouth

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ClinicalTrials.gov Identifier: NCT00911768
Recruitment Status : Completed
First Posted : June 2, 2009
Results First Posted : June 2, 2009
Last Update Posted : August 6, 2009
Sponsor:
Information provided by:
The Korean Society of Ginseng

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Xerostomia
Interventions Dietary Supplement: Korean Red Ginseng Powder Capsule
Dietary Supplement: Corn-starch powder with ginseng flavor
Enrollment 100
Recruitment Details 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
Pre-assignment Details 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).
Arm/Group Title Korean Red Ginseng Placebo
Hide Arm/Group Description Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks. Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Period Title: Overall Study
Started 50 50
Completed 44 46
Not Completed 6 4
Reason Not Completed
Protocol Violation             5             4
Withdrawal by Subject             1             0
Arm/Group Title Korean Red Ginseng Placebo Total
Hide Arm/Group Description Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks. Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
44
  88.0%
45
  90.0%
89.0
>=65 years
6
  12.0%
5
  10.0%
11.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
48.14  (15.97) 46.02  (16.14) 47.1  (16.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
28
  56.0%
26
  52.0%
54.0
Male
22
  44.0%
24
  48.0%
46.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title Visual Analogue Scale of Subjective Dry Mouth
Hide Description Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Korean Red Ginseng Placebo
Hide Arm/Group Description:
Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Overall Number of Participants Analyzed 44 46
Mean (Standard Deviation)
Unit of Measure: cm
5.21  (2.02) 5.03  (1.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Korean Red Ginseng, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.181
Confidence Interval 95%
-0.647 to 1.008
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.416
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Stimulated Salivary Flow Rates
Hide Description Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.
Arm/Group Title Korean Red Ginseng Placebo
Hide Arm/Group Description:
Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Overall Number of Participants Analyzed 44 46
Mean (Standard Deviation)
Unit of Measure: ml/min
1.046  (0.552) 1.392  (0.549)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Korean Red Ginseng, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A non-inferiority analysis was conducted. We just compared the difference of stimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.346
Confidence Interval 95%
-0.576 to -0.115
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.116
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Unstimulated Salivary Flow Rates
Hide Description Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.
Arm/Group Title Korean Red Ginseng Placebo
Hide Arm/Group Description:
Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
Overall Number of Participants Analyzed 44 46
Mean (Standard Deviation)
Unit of Measure: ml/min
0.220  (0.153) 0.266  (0.185)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Korean Red Ginseng, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A non-inferiority analysis was conducted. We just compared the difference of unstimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.086
Confidence Interval 95%
-0.155 to -0.017
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.035
Estimation Comments [Not Specified]
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: Jae-Woo Park, KMD, PhD
Organization: Kyung Hee East-West Neo Medical Center
Phone: +082-02-440-6219
Responsible Party: Jae-Woo Park, KMD, PhD, Kyung Hee East-West Neo Medical Center
ClinicalTrials.gov Identifier: NCT00911768     History of Changes
Other Study ID Numbers: KHNMC-OH-IRB 2007-007
First Submitted: March 3, 2009
First Posted: June 2, 2009
Results First Submitted: March 3, 2009
Results First Posted: June 2, 2009
Last Update Posted: August 6, 2009