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Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
This study has been completed.
Sponsor:
The Korean Society of Ginseng
Information provided by (Responsible Party):
JIN-MOO LEE, Kyung Hee University Gangdong Hospital
ClinicalTrials.gov Identifier:
NCT01664156
First received: August 8, 2012
Last updated: March 12, 2014
Last verified: March 2014
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Purpose
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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 | Intervention | Phase |
|---|---|---|
| Cold Hypersensitivity | Drug: Korean red ginseng Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial cold autoinflammatory syndrome
neonatal onset multisystem inflammatory disease
Genetic and Rare Diseases Information Center resources:
Familial Cold Autoinflammatory Syndrome
Cryopyrin-associated Periodic Syndrome
Familial Mediterranean Fever
U.S. FDA Resources
Further study details as provided by JIN-MOO LEE, Kyung Hee University Gangdong Hospital:
Primary Outcome Measures:
- The change of the infrared thermography of cold hypersensitivity on hands [ Time Frame: baseline and 8 weeks ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 80 |
| Study Start Date: | October 2012 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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| Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01664156
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664156
Locations
| Korea, Republic of | |
| Kyung Hee University Hospital at Gangdong | |
| Seoul, Gangdong-gu, Korea, Republic of, 134 727 | |
Sponsors and Collaborators
The Korean Society of Ginseng
Investigators
| Principal Investigator: | JIN-MOO LEE, Ph. D | Kyung Hee University Hospital at Gangdong |
More Information
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 |
| Study First Received: | August 8, 2012 |
| Last Updated: | March 12, 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 |
ClinicalTrials.gov processed this record on September 21, 2017