Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet - Full Text View

Purpose

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
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

MedlinePlus related topics: Allergy Foot Health

Genetic and Rare Diseases Information Center resources: Cryopyrin-associated Periodic Syndrome Familial Cold Autoinflammatory Syndrome Familial Mediterranean Fever

U.S. FDA Resources

Further study details as provided by The Korean Society of Ginseng:

Primary Outcome Measures:

The change of the infrared thermography of cold hypersensitivity on hands [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The change of the infrared thermography of cold hypersensitivity on feet [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
The change of cold stress test [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
The change of Distal-Dorsal Difference [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
The change of Heart Rate Variability [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
The change of 36-Item Short Form Health Survey [ Time Frame: baseline, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]


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
Genders 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

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, see Learn About Clinical Studies.

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 Gangdong Hospital

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Health Authority:	Korea: Food and Drug Administration

Keywords provided by The Korean Society of Ginseng:


Cold hypersensitivity Korean red ginseng Infrared thermography Cold stress test Distal-dorsal difference

Additional relevant MeSH terms:


Cryopyrin-Associated Periodic Syndromes Hypersensitivity Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases	Immune System Diseases Skin Diseases Skin Diseases, Genetic

ClinicalTrials.gov processed this record on February 27, 2015