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

This study has been completed.
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: March 12, 2014
Last verified: March 2014

August 8, 2012
March 12, 2014
October 2012
December 2013   (final data collection date for primary outcome measure)
The change of the infrared thermography of cold hypersensitivity on hands [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • The change of the infrared thermography of cold hypersensitivity on hands [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The change of the Visual Analogue Scale of cold hypersensitivity on hands [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01664156 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The change of the infrared thermography of cold hypersensitivity on feet [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The change of the Visual Analogue Scale of cold hypersensitivity on feet [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The change of cold stress test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The change of Distal-Dorsal Difference [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The change of Heart Rate Variability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The change of 36-Item Short Form Health Survey [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial
  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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cold Hypersensitivity
  • 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.
  • Drug: Placebo
  • 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).
    Intervention: Drug: Korean red 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).
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01664156
KHNMC-OH-IRB 2012-004
Yes
JIN-MOO LEE, Kyung Hee University Gangdong Hospital
The Korean Society of Ginseng
Not Provided
Principal Investigator: JIN-MOO LEE, Ph. D Kyung Hee University Gangdong Hospital
The Korean Society of Ginseng
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP