- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00911768
Effect of Korean Red Ginseng (KRG) on Dry Mouth
August 3, 2009 updated by: The Korean Society of Ginseng
PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
Study Overview
Status
Completed
Conditions
Detailed Description
Korean Red Ginseng
- Worldwide use
- A main herb of old oriental prescriptions for dry mouth
- Need for correct information by RCT
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 134-090
- Kyung Hee East-West Neo Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Dry mouth patients
Exclusion Criteria:
- Sjögren syndrome
- Irradiation related xerostomia
- Severe psychiatric diseases
- pregnancy or breast feeding women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Korean Red Ginseng group
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.
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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
Other Names:
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Placebo Comparator: Corn-starch powder with ginseng flavor
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.
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale of Subjective Dry Mouth
Time Frame: 8 weeks
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Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stimulated Salivary Flow Rates
Time Frame: 8 weeks
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Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
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8 weeks
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Unstimulated Salivary Flow Rates
Time Frame: 8 weeks
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Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jae-Woo Park, K.M.D., Ph.D, Kyung Hee East-West Neo Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
March 3, 2009
First Submitted That Met QC Criteria
April 7, 2009
First Posted (Estimate)
June 2, 2009
Study Record Updates
Last Update Posted (Estimate)
August 6, 2009
Last Update Submitted That Met QC Criteria
August 3, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHNMC-OH-IRB 2007-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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