title: The efficacy and safety of the Shaoyao Shujin tablet for knee osteoarthritis: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Knee osteoarthritis (KOA) is a major public health issue causing chronic disability as well as a burden on healthcare resources. In China, a herbal drug tablet has been used as an effective and conventional therapy to alleviate clinical symptoms caused by KOA. However, evidence gathered from systematic reviews or randomized controlled trials that validated herbal drugs for the management of osteoarthritic pain is weak. The purpose of this study is to explore the efficacy and safety of the Shaoyao Shujin tablet for the management of KOA in a short-term study.
  
  
  METHODS
  This trial is a multicenter randomized, double-blind, placebo-controlled study. A total of 276 patients will be randomized into 3 groups: (1) the high-dose Shaoyao Shujin tablet group (HD group), (2) the low-dose Shaoyao Shujin tablet group (LD group), and (3) the placebo tablet group (control group). In the three groups, four tablets will be administered three times per day for 6 weeks. Follow-up will be at regular intervals during a 10-week period with the Western Ontario and McMaster Universities Index (WOMAC) score, visual analog scale (VAS) score, and rescue medication use assessed as outcome measures.
  
  
  CONCLUSIONS
  This study will provide clinical evidence on the efficacy and safety of the Shaoyao Shujin tablet in treating KOA.
  
  
  BACKGROUND
  Chinese Cochrane Center ChiCTR-IPR- 15006194 , registered 4 April 2015.
authors.affiliation: Department of Orthopedic Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. CAOXUEWEI@126.COM.
authors.forename: Xue-Wei
authors.initials: XW
authors.lastname: Cao
authors.affiliation: Department of Orthopedic Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. 341127403@QQ.COM.
authors.forename: Da
authors.initials: D
authors.lastname: Guo
authors.affiliation: Department of Orthopedic Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. LIUJINWEN2003@126.COM.
authors.forename: Jin-Wen
authors.initials: JW
authors.lastname: Liu
authors.affiliation: Department of Orthopedic Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. niuwei@139.com.
authors.forename: Wei
authors.initials: W
authors.lastname: Niu
authors.affiliation: Department of Orthopedic Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. liujun.gdtcm@hotmail.com.
authors.forename: Jun
authors.initials: J
authors.lastname: Liu
authors.affiliation: The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. panjianke0324@126.com.
authors.forename: Jian-Ke
authors.initials: JK
authors.lastname: Pan
authors.affiliation: The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. 2323653@qq.com.
authors.forename: Hui
authors.initials: H
authors.lastname: Xie
authors.affiliation: Department of Statistical Secretary, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. 35635369@QQ.COM.
authors.forename: Wen-Wei
authors.initials: WW
authors.lastname: Ouyang
authors.affiliation: Department of Orthopedic Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, 111 Dade Road, Guangzhou, Guangdong, 510120, China. lindingkun.tcm@hotmail.com.
authors.forename: Ding-Kun
authors.initials: DK
authors.lastname: Lin
mesh_terms: D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D013607:Tablets
chemical_list: D004365:Drugs, Chinese Herbal; D013607:Tablets