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

March 12, 2014 updated by: JIN-MOO LEE, The Korean Society of Ginseng

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gangdong-gu
      • Seoul, Gangdong-gu, Korea, Republic of, 134 727
        • Kyung Hee University Hospital at Gangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of the infrared thermography of cold hypersensitivity on hands
Time Frame: baseline and 8 weeks
baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The change of the infrared thermography of cold hypersensitivity on feet
Time Frame: baseline and 8 weeks
baseline and 8 weeks
The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
Time Frame: baseline and 8 weeks
baseline and 8 weeks
The change of cold stress test
Time Frame: baseline and 8 weeks
baseline and 8 weeks
The change of Distal-Dorsal Difference
Time Frame: baseline and 8 weeks
baseline and 8 weeks
The change of Heart Rate Variability
Time Frame: baseline and 8 weeks
baseline and 8 weeks
The change of 36-Item Short Form Health Survey
Time Frame: baseline, 8 weeks, and 12 weeks
baseline, 8 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: JIN-MOO LEE, Ph. D, Kyung Hee University Hospital at Gangdong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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