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:
-
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 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