title: Evaluation on the efficacy and safety of Chinese herbal medication Xifeng Dingchan Pill in treating Parkinson's disease: study protocol of a multicenter, open-label, randomized active-controlled trial.
abstract: BACKGROUND
  Parkinson's disease (PD) is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine (TCM) has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill (XFDCP), a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease.
  
  
  METHODS
  This is a multicenter, randomized controlled trial. In total, 320 patients with early- (n = 160) and middle-stage PD (n = 160) will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group (n = 80) will be given XFDCP, and the control group (n = 80) will be given Madopar. Of the 160 patients with middle-stage PD, the trial group (n = 80) will be given XFDCP combined with Madopar and Piribedil, and the control group (n = 80) will be given Madopar and Piribedil. The Unified Parkinson's Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar's dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period.
  
  
  CONCLUSIONS
  It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages.
  
  
  BACKGROUND
  This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.
authors.affiliation: Department of Cerebropathy, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China; E-mail: mayunzhi6688@sohu.com.
authors.forename: Jie
authors.initials: J
authors.lastname: Zhang
authors.forename: Yun-zhi
authors.initials: YZ
authors.lastname: Ma
authors.forename: Xiao-ming
authors.initials: XM
authors.lastname: Shen
mesh_terms: D001545:Benserazide / Q000627:therapeutic use; D003627:Data Interpretation, Statistical; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use; D008516:Medicine, Chinese Traditional; D010300:Parkinson Disease / Q000188:drug therapy* / Q000523:psychology; D008517:Phytotherapy; D010891:Piribedil / Q000627:therapeutic use; D011788:Quality of Life
chemical_list: D004338:Drug Combinations; D004365:Drugs, Chinese Herbal; C005177:benserazide, levodopa drug combination; D007980:Levodopa; D001545:Benserazide; D010891:Piribedil