Clinical trial NCT01664156: Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
Official title: Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cold Hypersensitivity
Keywords: Cold hypersensitivity
Korean red ginseng
Infrared thermography
Cold stress test
Distal-dorsal difference
Lead sponsor: The Korean Society of Ginseng
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of the infrared thermography of cold hypersensitivity on hands
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: The change of the infrared thermography of cold hypersensitivity on feet
timeFrame: baseline and 8 weeks
measure: The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
timeFrame: baseline and 8 weeks
measure: The change of cold stress test
timeFrame: baseline and 8 weeks
measure: The change of Distal-Dorsal Difference
timeFrame: baseline and 8 weeks
measure: The change of Heart Rate Variability
timeFrame: baseline and 8 weeks
measure: The change of 36-Item Short Form Health Survey
timeFrame: baseline, 8 weeks, and 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Gangdong-gu
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: JIN-MOO LEE, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Park KS, Kim JW, Jo JY, Hwang DS, Lee CH, Jang JB, Lee KS, Yeo I, Lee JM. Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial. Trials. 2013 Dec 19;14:438. doi: 10.1186/1745-6215-14-438.