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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

  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.

Detailed Summary:

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.

Sponsor: The Korean Society of Ginseng

Current Primary Outcome: The change of the infrared thermography of cold hypersensitivity on hands [ Time Frame: baseline and 8 weeks ]

Original Primary Outcome:

  • The change of the infrared thermography of cold hypersensitivity on hands [ Time Frame: 8 weeks ]
  • The change of the Visual Analogue Scale of cold hypersensitivity on hands [ Time Frame: 8 weeks ]


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

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


Information By: The Korean Society of Ginseng

Dates:
Date Received: August 8, 2012
Date Started: October 2012
Date Completion:
Last Updated: March 12, 2014
Last Verified: March 2014