title: Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.
abstract: BACKGROUND
  Stable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris.
  
  
  METHODS
  This is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed.
  
  
  CONCLUSIONS
  The primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  ChiCTR-TRC-13003608, registered 18 June 2013.
authors.forename: Zhe
authors.initials: Z
authors.lastname: Zhang
authors.forename: Fan
authors.initials: F
authors.lastname: Zhang
authors.forename: Yang
authors.initials: Y
authors.lastname: Wang
authors.forename: Yi
authors.initials: Y
authors.lastname: Du
authors.forename: Huiyong
authors.initials: H
authors.lastname: Zhang
authors.forename: Dezhao
authors.initials: D
authors.lastname: Kong
authors.forename: Yue
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Liaoning University of Traditional Chinese Medicine, 79, Chong Shan Dong Lu Road, Huanggu District, Shenyang 110032, Liaoning, China. yangguanlin945@gmail.com.
authors.forename: Guanlin
authors.initials: G
authors.lastname: Yang
mesh_terms: D060050:Angina, Stable / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D002985:Clinical Protocols; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000379:methods*; D005996:Nitroglycerin / Q000008:administration & dosage; D012107:Research Design; D011795:Surveys and Questionnaires; D049490:Systems Biology; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage
chemical_list: D002317:Cardiovascular Agents; D004365:Drugs, Chinese Herbal; D014665:Vasodilator Agents; D005996:Nitroglycerin