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

Primary Purpose

Cold Hypersensitivity

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean red ginseng
Placebo
Sponsored by
The Korean Society of Ginseng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cold Hypersensitivity focused on measuring Cold hypersensitivity, Korean red ginseng, Infrared thermography, Cold stress test, Distal-dorsal difference

Eligibility Criteria

16 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Korean red ginseng

placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

The change of the infrared thermography of cold hypersensitivity on hands

Secondary Outcome Measures

The change of the infrared thermography of cold hypersensitivity on feet
The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
The change of cold stress test
The change of Distal-Dorsal Difference
The change of Heart Rate Variability
The change of 36-Item Short Form Health Survey

Full Information

First Posted
August 8, 2012
Last Updated
March 12, 2014
Sponsor
The Korean Society of Ginseng
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1. Study Identification

Unique Protocol Identification Number
NCT01664156
Brief Title
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
Official Title
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Korean Society of Ginseng

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Hypersensitivity
Keywords
Cold hypersensitivity, Korean red ginseng, Infrared thermography, Cold stress test, Distal-dorsal difference

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Korean red ginseng
Arm Type
Experimental
Arm Description
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).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Korean red ginseng
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The change of the infrared thermography of cold hypersensitivity on hands
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
The change of the infrared thermography of cold hypersensitivity on feet
Time Frame
baseline and 8 weeks
Title
The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
Time Frame
baseline and 8 weeks
Title
The change of cold stress test
Time Frame
baseline and 8 weeks
Title
The change of Distal-Dorsal Difference
Time Frame
baseline and 8 weeks
Title
The change of Heart Rate Variability
Time Frame
baseline and 8 weeks
Title
The change of 36-Item Short Form Health Survey
Time Frame
baseline, 8 weeks, and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIN-MOO LEE, Ph. D
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
State/Province
Gangdong-gu
ZIP/Postal Code
134 727
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22856358
Citation
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.
Results Reference
background
PubMed Identifier
24354675
Citation
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.
Results Reference
derived

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

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