title: CUPID: a protocol of a randomised controlled trial to identify characteristics of similar Chinese patent medicines.
abstract: BACKGROUND
  Traditional Chinese medicine (TCM) has accumulated some experience in curing stable angina pectoris (SAP) and efficacy has been demonstrated. Chinese patent medicines, known as modern dosage forms of TCM, can attain the desired effect in clinical application only with the guidance of TCM syndrome theory. However, due to their use by a large number of persons with little knowledge of TCM theories and practices, their efficacy and reputation have been seriously affected.
  
  
  METHODS
  Two common syndrome types of SAP in TCM, 'qi deficiency and blood stasis' and 'qi stagnation and blood stasis', will be studied in 144 subjects from four TCM hospitals in Tianjin in China using a partial crossover design. The two syndromes will be broken down into six symptom combinations; patients will select a combination of the most distressing to them, and then will be randomised into two groups. Each group, on the basis of routine medication, will be administered one kind of Chinese patent drug: Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills. The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team.
  
  
  BACKGROUND
  This protocol has been approved by the medical ethics committee of Tianjin University of TCM (registration number TJUTCM-EC20130005). The study is safe and reliable.
  
  
  BACKGROUND
  Chinese clinical trials register ChiCTR-TTRCC-14004406.
authors.affiliation: Tianjin Institute of Clinical Evaluation, Tianjin University of Traditional Chinese Medicine, Tianjin, China Center for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Hongbo
authors.initials: H
authors.lastname: Cao
authors.affiliation: Tianjin Institute of Clinical Evaluation, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Jingbo
authors.initials: J
authors.lastname: Zhai
authors.affiliation: Tianjin Institute of Clinical Evaluation, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Nan
authors.initials: N
authors.lastname: Li
authors.affiliation: Department of Geriatrics, Gansu Hospital of Traditional Chinese Medicine, Lanzhou, China.
authors.forename: Hongxia
authors.initials: H
authors.lastname: Cao
authors.affiliation: Center for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Xiang
authors.initials: X
authors.lastname: Lei
authors.affiliation: Center for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Wei
authors.identifier: http://orcid.org/0000-0003-2369-7878
authors.initials: W
authors.lastname: Mu
authors.affiliation: Tianjin Institute of Clinical Evaluation, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Zhi
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Tianjin Institute of Clinical Evaluation, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Wang
authors.affiliation: Tianjin Institute of Clinical Evaluation, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Hongcai
authors.initials: H
authors.lastname: Shang
mesh_terms: D060050:Angina, Stable / Q000188:drug therapy*; D002681:China; D002985:Clinical Protocols; D018592:Cross-Over Studies; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000379:methods*; D004366:Nonprescription Drugs; D008517:Phytotherapy / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D027561:Salvia miltiorrhiza
chemical_list: D004365:Drugs, Chinese Herbal; D004366:Nonprescription Drugs; C028972:dan-shen root extract
keywords: COMPLEMENTARY MEDICINE; STATISTICS & RESEARCH METHODS