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Objectives
Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity of hands and feet more effectively than placebo after 8 weeks administration of interventions- Korean red ginseng or the placebo.
Design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korean red ginseng | Experimental | The patients will receive Korean red ginseng(Korean Red Ginseng Powder Capsule®; Korea Ginseng Corporation, Daejeon, Korea). Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner). |
|
| placebo | Placebo Comparator | Placebo Korean red ginseng capsule contain cornstarch powder with the same color and taste as Korean red ginseng. Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Korean red ginseng | Drug | Korean red ginseng is a steamed form of Panax ginseng with preserved major constituents. It has been shown to possess more biological activity than panax ginseng. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the infrared thermography of cold hypersensitivity on hands | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the infrared thermography of cold hypersensitivity on feet | baseline and 8 weeks | |
| The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet | baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JIN-MOO LEE, Ph. D | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital at Gangdong | Seoul | Gangdong-gu | 134 727 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22856358 | Background | Hur YM, Chae JH, Chung KW, Kim JJ, Jeong HU, Kim JW, Seo SY, Kim KS. Feeling of cold hands and feet is a highly heritable phenotype. Twin Res Hum Genet. 2012 Apr;15(2):166-9. doi: 10.1375/twin.15.2.166. | |
| 24354675 | Derived | Park KS, Kim JW, Jo JY, Hwang DS, Lee CH, Jang JB, Lee KS, Yeo I, Lee JM. Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial. Trials. 2013 Dec 19;14:438. doi: 10.1186/1745-6215-14-438. |
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| ID | Term |
|---|---|
| C569627 | Cold Hypersensitivity |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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| Placebo | Drug |
|
| The change of cold stress test | baseline and 8 weeks |
| The change of Distal-Dorsal Difference | baseline and 8 weeks |
| The change of Heart Rate Variability | baseline and 8 weeks |
| The change of 36-Item Short Form Health Survey | baseline, 8 weeks, and 12 weeks |