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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2013

Detailed Description

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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).
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • The change of the infrared thermography of cold hypersensitivity on hands
    • Time Frame: baseline and 8 weeks

Secondary Measures

  • The change of the infrared thermography of cold hypersensitivity on feet
    • Time Frame: baseline and 8 weeks
  • The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
    • Time Frame: baseline and 8 weeks
  • The change of cold stress test
    • Time Frame: baseline and 8 weeks
  • The change of Distal-Dorsal Difference
    • Time Frame: baseline and 8 weeks
  • The change of Heart Rate Variability
    • Time Frame: baseline and 8 weeks
  • The change of 36-Item Short Form Health Survey
    • Time Frame: baseline, 8 weeks, and 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 16 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Korean Society of Ginseng
  • Provider of Information About this Clinical Study
    • Principal Investigator: JIN-MOO LEE, Professor – Kyung Hee University Hospital at Gangdong
  • Overall Official(s)
    • JIN-MOO LEE, Ph. D, Principal Investigator, Kyung Hee University Hospital at Gangdong

References

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.

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