Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
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|ClinicalTrials.gov Identifier: NCT01664156|
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : March 14, 2014
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Cold Hypersensitivity||Drug: Korean red ginseng Drug: Placebo||Phase 4|
- 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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||March 2014|
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).
Drug: Korean red ginseng
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).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664156
|Korea, Republic of|
|Kyung Hee University Hospital at Gangdong|
|Seoul, Gangdong-gu, Korea, Republic of, 134 727|
|Principal Investigator:||JIN-MOO LEE, Ph. D||Kyung Hee University Hospital at Gangdong|