Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index
Condition: Coronary Heart Disease; Stable Angina Pectoris
MeSH terms: Heart Diseases; Angina Pectoris; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Angina, Stable
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the trial is to take stable angina pectoris of coronary heart disease (CHD) as
      examples to build a standard evaluation system for efficacy of traditional Chinese medicine
      (TCM).

        1. Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes
           of CHD and self-administrated scale of Stable Angina Pectoris

        2. research on all indicators of CHD, and analyze their characteristics, target and
           function

        3. theory of Invigorating Spleen to Remove Phlegm or replenish Qi, and activating blood and
           dissolving stasis as an example for clinical efficacy evaluation.
    

Detailed description: 
      Clinical efficacy is the basis of traditional Chinese medicine development, and scientific
      evaluation of TCM clinical efficacy and its effectiveness is the way to push TCM modernized
      and international. TCM theories of Overall concept and Differentiation for life science and
      diseases are hard to be generally accepted. Besides, no unified and standard methods fit to
      evaluate the TCM clinical efficacy. Thus, there is a need to do a deeper research of
      methodology, evaluative index, and evaluative criteria in order to guide the evaluation of
      TCM clinical efficacy.

      Based on the situation above, the study aims to choose the best and characteristic evaluative
      index of clinical efficacy, compare the demand among practitioners, patients and care givers.
      After data collected, a new cluster of index among Biochemical, patients report outcomes,
      endpoint indicators, and TCM soft indicators could be constituted and analyzed to use in
      respective way according to their characteristics, target and function.
    

Intervention name(s): Louxiangdan Tongxin granules; TCM granules placebo; Chixiangshen Tongxin granules; TCM granule placebo plus western basis treatment; Western basis treatment
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): TCM treatment:
Decoction: Louxiangdan Tongxin granules Herbs:Danshen 10g、Chenxiang 1g、Gualou10g、Xiebai 10g、Banxia6g、Chuanxiong 6g 、Dangshen 10g、Zhiqiao 6g、Taoren 10g、Guizhi 6g Therapeutic Principle:Invigorating Spleen to Remove Phlegm and activating blood and dissolving stasis, at least 6 kinds of TCM herbs can be chosen and their dosages be adjusted according to Syndrome Differentiation.
Usage:Once 100ml, twice per day after breakfast and supper.; Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.; TCM treatment:
Decoction: Chixiangshen Tongxin granules Herbs: Chishao 10g, Chenxiang 1g, Danggui 10g, Jupi 10g, Yanhusuo 6g, Chuanxiong 6g, Dangshen 10g, Huangqi 6g, Taoren 10g, Honghua 10g Therapeutic Principle:Invigorating Spleen to Replenish Qi and activating blood and dissolving stasis, at least 6 kinds of TCM herbs can be chosen and their dosages be adjusted according to Syndrome Differentiation.
Usage:Once 100ml, twice per day after breakfast and supper.; Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.; Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary.
Other intervention name(s): Louxiangdan Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd; TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd; Chixiangshen Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd; TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd; Aspirin from Liaoning WanLong medicine Co.,Ltd; Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Complementary Therapies; Traditional Chinese Medicine; Quality of life; Seattle angina questionnaire (SAQ); SF-12; Measure Your Medical Outcome Profile (MYMOP); Phlegm and blood stasis Syndrome; Qi deficiency and blood stasis Syndrome; Invigorating Spleen to Remove Phlegm or replenish Qi; Activating blood and dissolving stasis; Traditional Chinese medicine SYndrome Scale (TCMsys); Patients Report Outcomes(PRO); clinical efficacy; evaluative index