Back to resultsEffect of Korean Red Ginseng (KRG) on Dry Mouth
Primary Purpose
Xerostomia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean Red Ginseng Powder Capsule
Corn-starch powder with ginseng flavor
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Panax ginseng(Korean Red Ginseng), Visual Analogue Scale, Salivary Flow Rates
Eligibility Criteria
Inclusion Criteria:
- Dry mouth patients
Exclusion Criteria:
- Sjögren syndrome
- Irradiation related xerostomia
- Severe psychiatric diseases
- pregnancy or breast feeding women
Sites / Locations
- Kyung Hee East-West Neo Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Korean Red Ginseng group
Corn-starch powder with ginseng flavor
Arm Description
The brand name of experimental drug is 'Capsule of Korean Red Ginseng Powder'. It consists of the powder of steamed root of Panax ginseng made by Korean Ginseng Corp.
The placebo of this study is corn-starch powder with Korean Red Ginseng flavor. It has the same shape, color and flavor like experimental drug.
Outcomes
Primary Outcome Measures
Visual Analogue Scale of Subjective Dry Mouth
Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.
Secondary Outcome Measures
Stimulated Salivary Flow Rates
Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Unstimulated Salivary Flow Rates
Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Full Information
NCT ID
NCT00911768
First Posted
March 3, 2009
Last Updated
August 3, 2009
Sponsor
The Korean Society of Ginseng
1. Study Identification
Unique Protocol Identification Number
NCT00911768
Brief Title
Effect of Korean Red Ginseng (KRG) on Dry Mouth
Official Title
PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Korean Society of Ginseng
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
Detailed Description
Korean Red Ginseng
Worldwide use
A main herb of old oriental prescriptions for dry mouth
Need for correct information by RCT
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
Xerostomia, Panax ginseng(Korean Red Ginseng), Visual Analogue Scale, Salivary Flow Rates
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Korean Red Ginseng group
Arm Type
Experimental
Arm Description
The brand name of experimental drug is 'Capsule of Korean Red Ginseng Powder'. It consists of the powder of steamed root of Panax ginseng made by Korean Ginseng Corp.
Arm Title
Corn-starch powder with ginseng flavor
Arm Type
Placebo Comparator
Arm Description
The placebo of this study is corn-starch powder with Korean Red Ginseng flavor. It has the same shape, color and flavor like experimental drug.
Intervention Type
Dietary Supplement
Intervention Name(s)
Korean Red Ginseng Powder Capsule
Other Intervention Name(s)
Brand Name: Korean Red Ginseng Powder Capsule
Intervention Description
Generic name: Korean Red Ginseng Powder Capsule Original herb name: Panax ginseng Form and contents: Capsule with powder of steamed root of 6-year Panax ginseng Dosage and frequency: 6 g per day (twice a day), Oral administration Administration duration: 56 days in the study
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn-starch powder with ginseng flavor
Other Intervention Name(s)
Corn-starch powder capsule with Korean Red Ginseng flavor
Intervention Description
There is no specific name because this intervention is placebo. This placebo has the same form, color and flavor as Korean Red Ginseng Powder Capsule.
The dosage form, dosage, frequency and duration is also same as experimental intervention (Korean Red Ginseng Powder Capsule).
Main contents: corn-starch with Panax ginseng flavor
Primary Outcome Measure Information:
Title
Visual Analogue Scale of Subjective Dry Mouth
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
Secondary Outcome Measure Information:
Title
Stimulated Salivary Flow Rates
Description
Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Time Frame
8 weeks
Title
Unstimulated Salivary Flow Rates
Description
Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dry mouth patients
Exclusion Criteria:
Sjögren syndrome
Irradiation related xerostomia
Severe psychiatric diseases
pregnancy or breast feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Woo Park, K.M.D., Ph.D
Organizational Affiliation
Kyung Hee East-West Neo Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee East-West Neo Medical Center
City
Seoul
ZIP/Postal Code
134-090
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Korean Red Ginseng (KRG) on Dry Mouth
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