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

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

1. Objectives

   1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women
   2. to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography

2. 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

• 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.

Inclusion Criteria:

1. Female aged 16 to 60 years
2. Women complaining cold hypersensitivity on hands and feet
3. Thermal deviation between the palm and the upper arm is higher than 0.3℃

Exclusion Criteria:

1. Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography
2. Alcohol abuse and alcoholic
3. History of cancer within 5 years
4. Severe depression
5. Hypertension and diabetes
6. Pregnancy or breastfeeding
7. Abnormal finding from blood test at screening visit
8. Allergic to Korean red ginseng
9. Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months