Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

1. 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
2. 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

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The change of the infrared thermography of cold hypersensitivity on hands [ Time Frame: baseline and 8 weeks ]

Secondary Outcome Measures :

1. The change of the infrared thermography of cold hypersensitivity on feet [ Time Frame: baseline and 8 weeks ]
2. The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet [ Time Frame: baseline and 8 weeks ]
3. The change of cold stress test [ Time Frame: baseline and 8 weeks ]
4. The change of Distal-Dorsal Difference [ Time Frame: baseline and 8 weeks ]
5. The change of Heart Rate Variability [ Time Frame: baseline and 8 weeks ]
6. The change of 36-Item Short Form Health Survey [ Time Frame: baseline, 8 weeks, and 12 weeks ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 60 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Female aged 16 to 60 years
2. Women complaining cold hypersensitivity on hands and feet
3. Thermal deviation between the palm and the upper arm is higher than 0.3℃

Exclusion Criteria:

1. Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography
2. Alcohol abuse and alcoholic
3. History of cancer within 5 years
4. Severe depression
5. Hypertension and diabetes
6. Pregnancy or breastfeeding
7. Abnormal finding from blood test at screening visit
8. Allergic to Korean red ginseng
9. Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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.

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
First Posted:	August 14, 2012
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