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Effect of Korean Red Ginseng (KRG) on Dry Mouth

This study has been completed.
Sponsor:
Information provided by:
The Korean Society of Ginseng
ClinicalTrials.gov Identifier:
NCT00911768
First received: March 3, 2009
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Xerostomia
 Dietary Supplement: Korean Red Ginseng Powder Capsule
Dietary Supplement: Corn-starch powder with ginseng flavor
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations

Resource links provided by NLM:

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources

Further study details as provided by The Korean Society of Ginseng:

Primary Outcome Measures:
  • Visual Analogue Scale of Subjective Dry Mouth [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stimulated Salivary Flow Rates [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Unstimulated Salivary Flow Rates [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
Other Name: Brand Name: Korean Red Ginseng Powder Capsule
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.
 Dietary Supplement: 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

Other Name: Corn-starch powder capsule with Korean Red Ginseng flavor

Detailed Description:

Korean Red Ginseng

  • Worldwide use
  • A main herb of old oriental prescriptions for dry mouth
  • Need for correct information by RCT
  Eligibility

Ages Eligible for Study:   19 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dry mouth patients

Exclusion Criteria:

  • Sjögren syndrome
  • Irradiation related xerostomia
  • Severe psychiatric diseases
  • pregnancy or breast feeding women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911768

Locations
Korea, Republic of
Kyung Hee East-West Neo Medical Center
Seoul, Korea, Republic of, 134-090
Sponsors and Collaborators
The Korean Society of Ginseng
Investigators
Principal Investigator: Jae-Woo Park, K.M.D., Ph.D Kyung Hee East-West Neo Medical Center
  More Information

No publications provided

Responsible Party: Jae-Woo Park, KMD, PhD, Kyung Hee East-West Neo Medical Center
ClinicalTrials.gov Identifier: NCT00911768     History of Changes
Other Study ID Numbers: KHNMC-OH-IRB 2007-007
Study First Received: March 3, 2009
Results First Received: March 3, 2009
Last Updated: August 3, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Korean Society of Ginseng:
Xerostomia
Panax ginseng(Korean Red Ginseng)
Visual Analogue Scale
Salivary Flow Rates

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 21, 2013