Xerostomia
Conditions
Keywords
Xerostomia, Panax ginseng(Korean Red Ginseng), Visual Analogue Scale, Salivary Flow Rates
Brief summary
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
Detailed description
Korean Red Ginseng * Worldwide use * A main herb of old oriental prescriptions for dry mouth * Need for correct information by RCT
Interventions
DIETARY_SUPPLEMENTKorean 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
DIETARY_SUPPLEMENTCorn-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
Sponsors
The Korean Society of Ginseng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* Dry mouth patients
Exclusion criteria
* Sjögren syndrome * Irradiation related xerostomia * Severe psychiatric diseases * pregnancy or breast feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale of Subjective Dry Mouth | 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
| Measure | Time frame | Description |
|---|---|---|
| Stimulated Salivary Flow Rates | 8 weeks | Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups. |
| Unstimulated Salivary Flow Rates | 8 weeks | Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups. |
Countries
South Korea
Participant flow
Recruitment details
Patients were recruited from the waiting room and consulting room of Oriental Clinic of Gastrointestinal diseases and Chronic fatigue of Kyung Hee East-West Neo-Medical Center (Seoul, Korea) between September 2007 and February 2008
Pre-assignment details
Totally, 133 participants were enrolled in the trial; 100 participants screened and 33 of them (women 18, men 15) were excluded because of abnormal liver function (1), present illness (2), a plan to pregnancy (1), and self refusals or disconnections (28).
Participants by arm
| Arm | Count |
|---|---|
| Korean Red Ginseng Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks. | 50 |
| Placebo Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 5 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Korean Red Ginseng | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11.0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 44 Participants | 89.0 Participants |
| Age Continuous | 46.02 years STANDARD_DEVIATION 16.14 | 48.14 years STANDARD_DEVIATION 15.97 | 47.1 years STANDARD_DEVIATION 16 |
| Region of Enrollment Korea, Republic of | 50 participants | 50 participants | 100.0 participants |
| Sex: Female, Male Female | 26 Participants | 28 Participants | 54.0 Participants |
| Sex: Female, Male Male | 24 Participants | 22 Participants | 46.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | — / — | — / — |
| serious Total, serious adverse events | — / — | — / — |
Outcome results
Primary
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.
Time frame: 8 weeks
Population: Because primay outcome of the study was changes of Visual Analogue Scale of Subjective Dry Mouth between 0, 4 and 8 weeks, per protocol analysis was applied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Visual Analogue Scale of Subjective Dry Mouth | 5.21 cm | Standard Deviation 2.02 |
| Placebo | Visual Analogue Scale of Subjective Dry Mouth | 5.03 cm | Standard Deviation 1.93 |
p-value: <0.0595% CI: [-0.647, 1.008]t-test, 2 sided
Secondary
Stimulated Salivary Flow Rates
Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Time frame: 8 weeks
Population: Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Stimulated Salivary Flow Rates | 1.046 ml/min | Standard Deviation 0.552 |
| Placebo | Stimulated Salivary Flow Rates | 1.392 ml/min | Standard Deviation 0.549 |
p-value: <0.0595% CI: [-0.576, -0.115]t-test, 2 sided
Secondary
Unstimulated Salivary Flow Rates
Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.
Time frame: 8 weeks
Population: Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Unstimulated Salivary Flow Rates | 0.220 ml/min | Standard Deviation 0.153 |
| Placebo | Unstimulated Salivary Flow Rates | 0.266 ml/min | Standard Deviation 0.185 |
p-value: <0.0595% CI: [-0.155, -0.017]t-test, 2 sided