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NCT00911768 Clinical Trial

Effect of Korean Red Ginseng (KRG) on Dry Mouth

Xerostomia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00911768
Other study ID # KHNMC-OH-IRB 2007-007
Secondary ID
Status Completed
Phase Phase 4
First received March 3, 2009
Last updated August 3, 2009
Start date September 2007
Est. completion date December 2008

Study information
Verified date August 2009
Source The Korean Society of Ginseng
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Description:

Korean Red Ginseng

- Worldwide use

- A main herb of old oriental prescriptions for dry mouth

- Need for correct information by RCT

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 76 Years
Eligibility Inclusion Criteria:

- Dry mouth patients

Exclusion Criteria:

- Sjögren syndrome

- Irradiation related xerostomia

- Severe psychiatric diseases

- pregnancy or breast feeding women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Korean Red Ginseng Powder Capsule
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
• Corn-starch powder with ginseng flavor
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

Locations
Country Name City State
Korea, Republic of Kyung Hee East-West Neo Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
The Korean Society of Ginseng

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale of Subjective Dry Mouth 8 weeks No
Secondary Stimulated Salivary Flow Rates 8 weeks No
Secondary Unstimulated Salivary Flow Rates 8 weeks No
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