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Completed

NCT Number: NCT01664156

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

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.

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Key information

Conditions

Cold Hypersensitivity

Age range

16 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 134 727, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Korean red ginseng

Drug

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

Drug

Primary outcomes

  1. The change of the infrared thermography of cold hypersensitivity on hands

    Time frame: baseline and 8 weeks

Secondary outcomes

  1. The change of the infrared thermography of cold hypersensitivity on feet

    Time frame: baseline and 8 weeks

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

    Time frame: baseline and 8 weeks

  3. The change of cold stress test

    Time frame: baseline and 8 weeks

  4. The change of Distal-Dorsal Difference

    Time frame: baseline and 8 weeks

  5. The change of Heart Rate Variability

    Time frame: baseline and 8 weeks

  6. The change of 36-Item Short Form Health Survey

    Time frame: baseline, 8 weeks, and 12 weeks

Sponsors and collaborators

Lead sponsor

The Korean Society of Ginseng

Other

Registry information

Official study title

Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 14, 2012
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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