Effect of Korean Red Ginseng (KRG) on Dry Mouth

August 3, 2009 updated by: The Korean Society of Ginseng

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

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

Study Overview

Detailed Description

Korean Red Ginseng

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 134-090
        • Kyung Hee East-West Neo Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dry mouth patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • 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.

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 Names:
  • Corn-starch powder capsule with Korean Red Ginseng flavor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale of Subjective Dry Mouth
Time Frame: 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.
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jae-Woo Park, K.M.D., Ph.D, Kyung Hee East-West Neo Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

June 2, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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