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

Cold Hypersensitivity Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cold Hypersensitivity
• Cryopyrin-Associated Periodic Syndromes
• Hypersensitivity

• NCT number: NCT01664156
• Study type: Interventional
• Source: The Korean Society of Ginseng
• Status: Completed
• Phase: Phase 4
• Start date: October 2012
• Completion date: March 2014