Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial.

Kyoung-Sun Park, Jin-Woo Kim, Jun-Young Jo, Deok-Sang Hwang, Chang-Hoon Lee, Jun-Bock Jang, Kyung-Sub Lee, Inkwon Yeo, Jin-Moo Lee

Journal: Trials 2014;14():438

PMID: 24354675

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Abstract

BACKGROUND

Cold hypersensitivity in the hands and feet (CHHF) is one of the most common complaints among Asians, especially in women. Korean red ginseng (KRG), which is a steamed form of Panax ginseng, has vasodilating action in the peripheral vessels and increases blood flow under cold stress. However, few studies have evaluated the effect of KRG on cold hypersensitivity.

METHODS/DESIGN

This trial is a randomized, double-blind, placebo-controlled trial in 80 CHHF patients. The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea. The participants will take KRG or a placebo for eight weeks, after which they will be followed-up for four weeks. During the administration period, six capsules of 500 mg KRG or placebo will be provided twice a day. The primary outcome is change of skin temperature in the hands between baseline and after treatment. The secondary outcomes include the visual analogue scale scores of cold hypersensitivity in the hands, change of skin temperature and the VAS scores of cold hypersensitivity in the feet, the recovery rate of the skin temperature by the cold stress test of the hands, the distal-dorsal difference of the hands, power variables of heart rate variability, and the 36-item short form health survey.

DISCUSSION

This study is the first trial to evaluate the efficacy of KRG on CHHF by using infrared thermography. Our study will provide basic evidence regarding CHHF.

TRIAL REGISTRATION

CliniacalTrials.gov NCT01664156.

Address: Department of Gynecology, College of Korean Medicine, Kyung Hee University, Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea. [email protected].

DOI: 10.1186/1745-6215-14-438

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MeSH Terms: Adolescent, Adult, Clinical Protocols, Cryopyrin-Associated Periodic Syndromes, Double-Blind Method, Female, Foot, Hand, Hospitals, University, Humans, Medicine, Korean Traditional, Middle Aged, Panax, Phytotherapy, Plant Preparations, Plant Roots, Plants, Medicinal, Republic of Korea, Research Design, Skin, Skin Temperature, Surveys and Questionnaires, Thermography, Thermosensing, Time Factors, Treatment Outcome, Vasodilator Agents, Young Adult