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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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.
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
The change of the infrared thermography of cold hypersensitivity on hands
Time frame: baseline and 8 weeks
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
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