title: Yukmijihwang-tang for the treatment of xerostomia in the elderly: study protocol for a randomized, double-blind, placebo-controlled, two-center trial.
abstract: BACKGROUND
  Xerostomia, a subjective sense of dry mouth, is not generally regarded a disease despite its high prevalence among the elderly, and therefore continues to impair affected patients' quality of life. In traditional Korean medicine, 'Yin-Deficiency' has been implicated in the pathogenesis of xerostomia among the elderly. Yukmijihwang-tang is a famous herbal prescription used to relieve 'Yin-Deficiency', and reportedly has antioxidant effects; therefore, it is postulated that Yukmijihwang-tang can be used to treat xerostomia in the elderly. However, to our knowledge, no clinical trial has been conducted on the effects of Yukmijihwang-tang on xerostomia. Thus, we designed a randomized clinical trial to investigate the effects and safety of Yukmijihwang-tang on xerostomia in the elderly. In addition, we will clarify the aforementioned assumption that 'Yin-Deficiency' is the major cause of xerostomia in the elderly by identifying a correlation between xerostomia and 'Yin-Deficiency'.
  
  
  METHODS
  This randomized, double-blind, placebo-controlled trial will be carried out at two centers: Kyung Hee University Korean Medicine Hospital and Kyung Hee University Hospital at Gangdong. We will recruit 96 subjects aged 60-80 years who have experienced xerostomia for 3 months prior to participation. Subjects who present with score >40 on the visual analogue scale for xerostomia and unstimulated salivary flow rate under 0.3mL/min will be included and the randomization will be carried out by an independent statistician by using a random number creation program. The subjects and all researchers except the statistician will be blinded to the group assignment. Yukmijihwang-tang or placebo will be administered to each group for 8 weeks. The primary outcome is change in the scores for the visual analogue scale for xerostomia and the dry mouth symptom questionnaire from 0 to 8 weeks.
  
  
  CONCLUSIONS
  It will be assessed whether Yukmijihwang-tang can be used as a new herbal treatment for xerostomia in the elderly by demonstrating its therapeutic effects in a well-designed clinical trial.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01579877.
authors.affiliation: Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea. oridoc@khu.ac.kr.
authors.forename: Gajin
authors.initials: G
authors.lastname: Han
authors.forename: Jae-Woo
authors.initials: JW
authors.lastname: Park
authors.forename: Seok-Jae
authors.initials: SJ
authors.lastname: Ko
authors.forename: Jihee
authors.initials: J
authors.lastname: Son
authors.forename: Jongki
authors.initials: J
authors.lastname: Seon
authors.forename: Juyeon
authors.initials: J
authors.lastname: Kim
authors.forename: Seulki
authors.initials: S
authors.lastname: Kim
authors.forename: Inkwon
authors.initials: I
authors.lastname: Yeo
authors.forename: Bongha
authors.initials: B
authors.lastname: Ryu
authors.forename: Jinsung
authors.initials: J
authors.lastname: Kim
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D006785:Hospitals, University; D006801:Humans; D055670:Medicine, Korean Traditional; D008875:Middle Aged; D008517:Phytotherapy; D010946:Plants, Medicinal; D056910:Republic of Korea; D012107:Research Design; D012472:Salivation / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome; D014987:Xerostomia / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D016710:Yin Deficiency
chemical_list: D000975:Antioxidants; D004365:Drugs, Chinese Herbal; C000589716:yukmijihwang-tang