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Completed

NCT Number: NCT00911768

Effect of Korean Red Ginseng (KRG) on Dry Mouth

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

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

19 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyung Hee East-West Neo Medical Center

Seoul, 134-090, South Korea

About this study

Korean Red Ginseng

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dry mouth patients

Exclusion criteria

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

Treatment and study plan

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

Other names: Brand Name: Korean Red Ginseng Powder Capsule

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Stimulated Salivary Flow Rates

    Time frame: 8 weeks

    Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.

  2. Unstimulated Salivary Flow Rates

    Time frame: 8 weeks

    Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.

Sponsors and collaborators

Lead sponsor

The Korean Society of Ginseng

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 2, 2009
Registry last updated
Aug 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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