Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet

Study Overview
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Brief Summary
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Objectives to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography 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.

Detailed Description
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Design This trial is a randomized, double blind, placebo controlled trial with 80 patients. The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea. Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up during 4 weeks. During the administration period, 6 capsules 2 times a day (1h after breakfast and dinner) of Korean red ginseng or its placebo will be provided.

Official Title
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Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Cold Hypersensitivity

Intervention / Treatment
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* Drug: Korean red ginseng
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged 16 to 60 years Women complaining cold hypersensitivity on hands and feet Thermal deviation between the palm and the upper arm is higher than 0.3℃ Exclusion Criteria: Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography Alcohol abuse and alcoholic History of cancer within 5 years Severe depression Hypertension and diabetes Pregnancy or breastfeeding Abnormal finding from blood test at screening visit Allergic to Korean red ginseng Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean red ginseng<br>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). | Drug: Korean red ginseng<br>* 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.<br>|
| Placebo Comparator: placebo<br>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). | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the infrared thermography of cold hypersensitivity on hands |  | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cold hypersensitivity, Korean red ginseng, Infrared thermography, Cold stress test, Distal-dorsal difference