Xerostomia Clinical Trial
Official title:
PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations
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 |
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyung Hee East-West Neo Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
The Korean Society of Ginseng |
Korea, Republic of,
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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