title: Oral granulated Chinese herbal medicine (YXBCM01) plus topical calcipotriol for psoriasis vulgaris: study protocol for a double-blind, randomized placebo controlled trial.
abstract: BACKGROUND
  Probably related to immune dysfunction, psoriasis vulgaris is a chronic, painful, disfiguring and disabling dermatological disease, carrying an increased risk of serious comorbidities. Current conventional therapies can be costly, show risks of side effects and have limited efficacy, with relapse common on treatment cessation. Chinese herbal medicine is effective in treating psoriasis vulgaris. However, any benefit of adding Chinese herbal medicine to conventional treatments when treating psoriasis vulgaris is yet to be determined.
  
  
  METHODS
  This is a pilot randomized, placebo controlled, double-blinded trial. The pilot is primarily to determine the feasibility of undertaking a full size randomized trial. Thirty participants with psoriasis vulgaris and Psoriasis Area Severity Index (PASI) scores ≥ 7 and ≤ 12 will be included. Participants will be randomized (in a 1:1 ratio) to receive oral granulated Chinese herbal medicine YXBCM01 plus topical calcipotriol 0.005% or oral YXBCM01 placebo plus topical calcipotriol 0.005% treatment for 12 weeks, with a 12-week follow-up phase. The Chinese herbal medicine or placebo will be administered orally as dissolvable granules. The primary outcome measure will be PASI change (%) from baseline to the end of treatment phase. Secondary outcomes will include safety, key psoriasis-related cytokine changes (for example, IL12, IL17 and IL 23) during the entire trial and symptom relapse rates at the end of the follow-up phase.
  
  
  CONCLUSIONS
  The study will evaluate the feasibility of a randomized controlled trial investigating combined conventional and Chinese herbal medicine therapy for psoriasis vulgaris. The ingredients of YXBCM01 were selected based on literature, the expert opinion on herbal medicine and pre-clinical evidence, for instance Chinese herbal medicine possesses anti-inflammatory or antiproliferative properties.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12614000493640.
authors.forename: Shefton
authors.initials: S
authors.lastname: Parker
authors.forename: Anthony Lin
authors.initials: AL
authors.lastname: Zhang
authors.forename: Claire Shuiqing
authors.initials: CS
authors.lastname: Zhang
authors.forename: Greg
authors.initials: G
authors.lastname: Goodman
authors.forename: Zehuai
authors.initials: Z
authors.lastname: Wen
authors.affiliation: School of Health Sciences, RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia. luchuanjian888@vip.sina.com.
authors.forename: Chuanjian
authors.initials: C
authors.lastname: Lu
authors.forename: Charlie Changlie
authors.initials: CC
authors.lastname: Xue
mesh_terms: D000279:Administration, Cutaneous; D000284:Administration, Oral; D015415:Biomarkers / Q000097:blood; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002985:Clinical Protocols; D016207:Cytokines / Q000097:blood; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D010865:Pilot Projects; D011565:Psoriasis / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D012008:Recurrence; D012074:Remission Induction; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014739:Victoria
chemical_list: D015415:Biomarkers; D016207:Cytokines; D003879:Dermatologic Agents; D004365:Drugs, Chinese Herbal; D018836:Inflammation Mediators; C000599989:YXBCM01; C055085:calcipotriene; D002117:Calcitriol