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

• The change of the infrared thermography of cold hypersensitivity on hands [ Time Frame: baseline, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
• The change of the Visual Analogue Scale of cold hypersensitivity on hands [ Time Frame: baseline, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]

• The change of the infrared thermography of cold hypersensitivity on feet [ Time Frame: baseline, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
• The change of the Visual Analogue Scale of cold hypersensitivity on feet [ Time Frame: baseline, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
• The change of cold stress test [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• The change of Distal-Dorsal Difference [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• The change of Heart Rate Variability [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• The change of 36-Item Short Form Health Survey [ Time Frame: baseline, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]

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.

• Drug: Korean red ginseng
  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.
• Drug: Placebo

• Experimental: Korean red ginseng
  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).
  Intervention: Drug: Korean red ginseng
• Placebo Comparator: placebo
  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).
  Intervention: Drug: Placebo

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