Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01664156 |
Recruitment Status
:
Completed
First Posted
: August 14, 2012
Last Update Posted
: March 14, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
-
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cold Hypersensitivity | Drug: Korean red ginseng Drug: Placebo | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |

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).
|
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).
|
Drug: Placebo |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | JIN-MOO LEE, Professor, Kyung Hee University Gangdong Hospital |
ClinicalTrials.gov Identifier: | NCT01664156 History of Changes |
Other Study ID Numbers: |
KHNMC-OH-IRB 2012-004 |
First Posted: | August 14, 2012 Key Record Dates |
Last Update Posted: | March 14, 2014 |
Last Verified: | March 2014 |
Keywords provided by JIN-MOO LEE, Kyung Hee University Gangdong Hospital:
Cold hypersensitivity Korean red ginseng Infrared thermography Cold stress test Distal-dorsal difference |
Additional relevant MeSH terms:
Hypersensitivity Cryopyrin-Associated Periodic Syndromes Immune System Diseases Hereditary Autoinflammatory Diseases |
Genetic Diseases, Inborn Skin Diseases, Genetic Skin Diseases |