title: Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  CliniacalTrials.gov NCT01664156.
authors.forename: Kyoung-Sun
authors.initials: KS
authors.lastname: Park
authors.forename: Jin-Woo
authors.initials: JW
authors.lastname: Kim
authors.forename: Jun-Young
authors.initials: JY
authors.lastname: Jo
authors.forename: Deok-Sang
authors.initials: DS
authors.lastname: Hwang
authors.forename: Chang-Hoon
authors.initials: CH
authors.lastname: Lee
authors.forename: Jun-Bock
authors.initials: JB
authors.lastname: Jang
authors.forename: Kyung-Sub
authors.initials: KS
authors.lastname: Lee
authors.forename: Inkwon
authors.initials: I
authors.lastname: Yeo
authors.affiliation: Department of Gynecology, College of Korean Medicine, Kyung Hee University, Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea. hanbang9597@hanmail.net.
authors.forename: Jin-Moo
authors.initials: JM
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D056587:Cryopyrin-Associated Periodic Syndromes / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005528:Foot; D006225:Hand; D006785:Hospitals, University; D006801:Humans; D055670:Medicine, Korean Traditional; D008875:Middle Aged; D005894:Panax; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D018517:Plant Roots; D010946:Plants, Medicinal; D056910:Republic of Korea; D012107:Research Design; D012867:Skin / Q000098:blood supply* / Q000294:innervation*; D012881:Skin Temperature / Q000187:drug effects*; D011795:Surveys and Questionnaires; D013817:Thermography; D013697:Thermosensing / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D028321:Plant Preparations; D014665:Vasodilator Agents