Title

Effect of Korean Red Ginseng (KRG) on Dry Mouth
PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    ginseng ...
  • Study Participants

    100
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
Korean Red Ginseng

Worldwide use
A main herb of old oriental prescriptions for dry mouth
Need for correct information by RCT
Study Started
Sep 30
2007
Primary Completion
May 31
2008
Study Completion
Dec 31
2008
Results Posted
Jun 02
2009
Estimate
Last Update
Aug 06
2009
Estimate

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 names: Brand Name: Korean Red Ginseng Powder Capsule

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

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.

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.

Criteria

Inclusion Criteria:

Dry mouth patients

Exclusion Criteria:

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

Summary

Korean Red Ginseng

Placebo

All Events

Event Type Organ System Event Term

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.

Korean Red Ginseng

5.21
cm (Mean)
Standard Deviation: 2.02

Placebo

5.03
cm (Mean)
Standard Deviation: 1.93

Unstimulated Salivary Flow Rates

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

Korean Red Ginseng

0.22
ml/min (Mean)
Standard Deviation: 0.153

Placebo

0.266
ml/min (Mean)
Standard Deviation: 0.185

Stimulated Salivary Flow Rates

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

Korean Red Ginseng

1.046
ml/min (Mean)
Standard Deviation: 0.552

Placebo

1.392
ml/min (Mean)
Standard Deviation: 0.549

Total

100
Participants

Age Continuous

47.1
years (Mean)
Standard Deviation: 16.0

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Korean Red Ginseng

Placebo

Drop/Withdrawal Reasons

Korean Red Ginseng

Placebo