Effect of Korean Red Ginseng (KRG) on Dry Mouth

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).

Detailed Description
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Korean Red Ginseng Worldwide use A main herb of old oriental prescriptions for dry mouth Need for correct information by RCT

Official Title
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PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations

Conditions
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Xerostomia

Intervention / Treatment
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* Dietary Supplement: Korean Red Ginseng Powder Capsule
* Dietary Supplement: Corn-starch powder with ginseng flavor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dry mouth patients Exclusion Criteria: Sjögren syndrome Irradiation related xerostomia Severe psychiatric diseases pregnancy or breast feeding women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean Red Ginseng group<br>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. | Dietary Supplement: Korean Red Ginseng Powder Capsule<br>* 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<br>* Other names: Brand Name: Korean Red Ginseng Powder Capsule;|
| Placebo Comparator: Corn-starch powder with ginseng flavor<br>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. | Dietary Supplement: Corn-starch powder with ginseng flavor<br>* 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<br>* Other names: Corn-starch powder capsule with Korean Red Ginseng flavor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulated Salivary Flow Rates | Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups. | 8 weeks | 
| Unstimulated Salivary Flow Rates | Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerostomia, Panax ginseng(Korean Red Ginseng), Visual Analogue Scale, Salivary Flow Rates