Effect of Korean Red Ginseng (KRG) on Dry Mouth

Phase 4

Completed

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

• Registration Number: NCT00911768
• Lead Sponsor: The Korean Society of Ginseng

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

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-05
• Study Completion: 2008-12
• Study First Submitted: 2009-03-03
• Results First Submitted: 2009-03-03
• Study First Submitted QC: 2009-04-07
• Results First Submitted QC: 2009-04-07
• Study First Posted: 2009-06-02
• Results First Posted: 2009-06-02
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Dry mouth patients

Exclusion Criteria

• Sjögren syndrome
• Irradiation related xerostomia
• Severe psychiatric diseases
• pregnancy or breast feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Korean Red Ginseng group	Korean Red Ginseng Powder Capsule	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.
Corn-starch powder with ginseng flavor	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale of Subjective Dry Mouth	8 weeks	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

Name	Time	Method
Stimulated Salivary Flow Rates	8 weeks	Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Unstimulated Salivary Flow Rates	8 weeks	Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.

Trial Locations

Locations (1)

Kyung Hee East-West Neo Medical Center; 🇰🇷 Seoul, Korea, Republic of