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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
480
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.
Affiliated hospital of Changchun university of TCM
Changchun, Jilin, China
Jilin integrative Chinese and western medicine hospital
Changchun, Jilin, China
Dalian integrative of Chinese and Western medicine hospital
Dalian, Liaoning, China
Dandong TCM hospital
Dandong, Liaoning, China
Fuxin TCM hospital
Fuxin, Liaoning, China
Affiliated hospital of Liaoning university of TCM 2
Shenyang, Liaoning, China
Affiliated hospital of Liaoning university of TCM
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Yingkou TCM hospital
Yingkou, Liaoning, China
Affiliated hospital of Tianjin university of TCM
Tianjin, Tianjin Municipality, China
TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed)
Time frame: Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
New developed Quality of life evaluative index: patients report outcomes for SAP
Time frame: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
New developed Quality of life evaluative index: self-administrated scale of SAP
Time frame: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification
Time frame: Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week; and all except MYMOP taken one more at expected day 7 in screen
Biochemical index: ECG, ECG exercise test, blood lipids, blood glucose (fasting glucose), Blood, urine, liver function, renal function, coagulation, echocardiography (including heart function), coronary CT (some hospitals choose to do)
Time frame: Taken at expected day 7 in the screening period (baseline) and Change from Baseline in 8th week
Quality of life evaluative index: Seattle angina questionnaire (SAQ)
Time frame: Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week
Quality of life evaluative index: short form-12 (SF-12)
Time frame: Taken at day 1 (baseline), Change from Baseline in 2nd, 4th, 8th, 12th week
TCM characteristics evaluative index: Traditional Chinese medicine Syndrome Scale 2 (criteria)
Time frame: Taken at expected day 7 in the Screening period,and Change from Baseline in 2nd,4th,8th week
Endpoint index (Cardiovascular events, non-cardiovascular events, death, hospitalization due to coronary heart disease cases)
Time frame: Taken at 2nd, 4th, 8th, 12th, 26th week
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