Cold Hypersensitivity
Conditions
Keywords
Cold hypersensitivity, Korean red ginseng, Infrared thermography, Cold stress test, Distal-dorsal difference
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 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
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.
DRUGPlacebo
Sponsors
The Korean Society of Ginseng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of the infrared thermography of cold hypersensitivity on hands | baseline and 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet | baseline and 8 weeks |
| The change of cold stress test | baseline and 8 weeks |
| The change of the infrared thermography of cold hypersensitivity on feet | baseline and 8 weeks |
| The change of Heart Rate Variability | baseline and 8 weeks |
| The change of 36-Item Short Form Health Survey | baseline, 8 weeks, and 12 weeks |
| The change of Distal-Dorsal Difference | baseline and 8 weeks |
Countries
South Korea
Outcome results
None listed