Effect of Korean Red Ginseng (KRG) on Dry Mouth

NCT00911768 | Completed Phase 4 Results

• 1 other identifier: KHNMC-OH-IRB 2007-007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Xerostomia

Keywords

Xerostomia; Panax ginseng(Korean Red Ginseng); Visual Analogue Scale; Salivary Flow Rates

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale of Subjective Dry Mouth

  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 Outcomes (2)

• Stimulated Salivary Flow Rates

  8 weeks

• Unstimulated Salivary Flow Rates

  8 weeks

Study Arms (2)

Korean Red Ginseng group

EXPERIMENTAL

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

Corn-starch powder with ginseng flavor

PLACEBO COMPARATOR

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

Interventions

Korean Red Ginseng Powder Capsule 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

Also known as: Brand Name: Korean Red Ginseng Powder Capsule

Korean Red Ginseng group

Corn-starch powder with ginseng flavor 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

Also known as: Corn-starch powder capsule with Korean Red Ginseng flavor

Corn-starch powder with ginseng flavor

Eligibility Criteria

• Age: 19 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dry mouth patients

You may not qualify if:

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

Sponsors & Collaborators

• The Korean Society of Ginseng: lead

Study Sites (1)

Kyung Hee East-West Neo Medical Center

Seoul, 134-090, South Korea

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Jae-Woo Park, KMD, PhD
• Organization: Kyung Hee East-West Neo Medical Center

pjw2907@khu.ac.kr

+082-02-440-6219

Study Officials

• Jae-Woo Park, K.M.D., Ph.D

  Kyung Hee East-West Neo Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: June 2, 2009
• Study Start: September 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 6, 2009
• Results First Posted: June 2, 2009

Record last verified: 2009-08

Locations

KR (1)