- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01664156
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
March 12, 2014 updated by: JIN-MOO LEE, The Korean Society of Ginseng
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gangdong-gu
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Seoul, Gangdong-gu, Korea, Republic of, 134 727
- Kyung Hee University Hospital at Gangdong
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female aged 16 to 60 years
- Women complaining cold hypersensitivity on hands and feet
- Thermal deviation between the palm and the upper arm is higher than 0.3℃
Exclusion Criteria:
- Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography
- Alcohol abuse and alcoholic
- History of cancer within 5 years
- Severe depression
- Hypertension and diabetes
- Pregnancy or breastfeeding
- Abnormal finding from blood test at screening visit
- Allergic to Korean red ginseng
- Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Korean red ginseng
The patients will receive Korean red ginseng(Korean Red Ginseng Powder Capsule®; Korea Ginseng Corporation, Daejeon, Korea).
Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).
|
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.
|
Placebo Comparator: placebo
Placebo Korean red ginseng capsule contain cornstarch powder with the same color and taste as Korean red ginseng.
Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of the infrared thermography of cold hypersensitivity on hands
Time Frame: baseline and 8 weeks
|
baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of the infrared thermography of cold hypersensitivity on feet
Time Frame: baseline and 8 weeks
|
baseline and 8 weeks
|
The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
Time Frame: baseline and 8 weeks
|
baseline and 8 weeks
|
The change of cold stress test
Time Frame: baseline and 8 weeks
|
baseline and 8 weeks
|
The change of Distal-Dorsal Difference
Time Frame: baseline and 8 weeks
|
baseline and 8 weeks
|
The change of Heart Rate Variability
Time Frame: baseline and 8 weeks
|
baseline and 8 weeks
|
The change of 36-Item Short Form Health Survey
Time Frame: baseline, 8 weeks, and 12 weeks
|
baseline, 8 weeks, and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JIN-MOO LEE, Ph. D, Kyung Hee University Hospital at Gangdong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
August 8, 2012
First Submitted That Met QC Criteria
August 13, 2012
First Posted (Estimate)
August 14, 2012
Study Record Updates
Last Update Posted (Estimate)
March 14, 2014
Last Update Submitted That Met QC Criteria
March 12, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHNMC-OH-IRB 2012-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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