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The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
Korean Red Ginseng
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulated Salivary Flow Rates | Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups. | 8 weeks |
| Unstimulated Salivary Flow Rates | Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Woo Park, K.M.D., Ph.D | Kyung Hee East-West Neo Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee East-West Neo Medical Center | Seoul | 134-090 | South Korea |
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).
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Korean Red Ginseng | Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks. |
| FG001 | Placebo | Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Korean Red Ginseng | Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks. |
| BG001 | Placebo | Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | cm | 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Korean Red Ginseng | Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jae-Woo Park, KMD, PhD | Kyung Hee East-West Neo Medical Center | +082-02-440-6219 | pjw2907@khu.ac.kr |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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 |
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| 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Stimulated Salivary Flow Rates | Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups. | Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied. | Posted | Jun 2009 | Mean | Standard Deviation | ml/min | 8 weeks |
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| Secondary | Unstimulated Salivary Flow Rates | Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups. | Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied. | Posted | Apr 2009 | Mean | Standard Deviation | ml/min | 8 weeks |
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| EG001 | Placebo | Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks. |
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