Effect of Korean Red Ginseng (KRG) on Dry Mouth

NCT ID: NCT00911768

Last Updated: 2009-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Korean Red Ginseng

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

Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Korean Red Ginseng Powder Capsule

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type PLACEBO_COMPARATOR

Corn-starch powder with ginseng flavor

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Brand Name: Korean Red Ginseng Powder Capsule Corn-starch powder capsule with Korean Red Ginseng flavor

Eligibility Criteria

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Inclusion Criteria

* Dry mouth patients

Exclusion Criteria

* Sjögren syndrome
* Irradiation related xerostomia
* Severe psychiatric diseases
* pregnancy or breast feeding women
Minimum Eligible Age

19 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Korean Society of Ginseng

OTHER

Sponsor Role lead

Responsible Party

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Kyung Hee East-West Neo Medical Center

Principal Investigators

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Jae-Woo Park, K.M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee East-West Neo Medical Center

Locations

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Kyung Hee East-West Neo Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KHNMC-OH-IRB 2007-007

Identifier Type: -

Identifier Source: org_study_id

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