NCT01664156

Brief Summary

  1. 1.Objectives
  2. 2.to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women
  3. 3.to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography
  4. 4.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

August 8, 2012

Last Update Submit

March 12, 2014

Conditions

Cold Hypersensitivity

Keywords

Cold hypersensitivityKorean red ginsengInfrared thermographyCold stress testDistal-dorsal difference

Outcome Measures

Primary Outcomes (1)

  • The change of the infrared thermography of cold hypersensitivity on hands

    baseline and 8 weeks

Secondary Outcomes (6)

  • The change of the infrared thermography of cold hypersensitivity on feet

    baseline and 8 weeks

  • The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet

    baseline and 8 weeks

  • The change of cold stress test

    baseline and 8 weeks

  • The change of Distal-Dorsal Difference

    baseline and 8 weeks

  • The change of Heart Rate Variability

    baseline and 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Korean red ginseng

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Korean red ginsengDRUG

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.

Korean red ginseng
PlaceboDRUG
placebo

Eligibility Criteria

Age16 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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℃

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 134 727, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 22856358BACKGROUND

  • 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.

    PMID: 24354675DERIVED

MeSH Terms

Conditions

Cold Hypersensitivity

Interventions

Asian ginseng

Study Officials

  • JIN-MOO LEE, Ph. D

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 14, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

KR(1)