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

This study is not yet open for participant recruitment.
Verified August 2012 by The Korean Society of Ginseng
Sponsor:
Information provided by (Responsible Party):
JIN-MOO LEE, Kyung Hee University Gangdong Hospital
ClinicalTrials.gov Identifier:
NCT01664156
First received: August 8, 2012
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

  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 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:

MedlinePlus related topics: Allergy Foot Health
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, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
  • The change of the Visual Analogue Scale of cold hypersensitivity on hands [ Time Frame: baseline, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of the infrared thermography of cold hypersensitivity on feet [ Time Frame: baseline, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
  • The change of the Visual Analogue Scale of cold hypersensitivity on feet [ Time Frame: baseline, 8 weeks, and 12 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 ]

Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: February 2014
Estimated 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:

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664156

Locations
Korea, Republic of
Kyung Hee University Hospital at Gangdong Not yet recruiting
Seoul, Gangdong-gu, Korea, Republic of, 134 727
Contact: KYOUNGSUN PARK     +82-10-2582-7313     lovepks82@naver.com    
Principal Investigator: JIN-MOO LEE, Ph D            
Sponsors and Collaborators
The Korean Society of Ginseng
Investigators
Principal Investigator: JIN-MOO LEE, Ph. D Kyung Hee University Gangdong Hospital
  More Information

Publications:

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: August 13, 2012
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:
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 May 19, 2013