Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

Study Overview
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Brief Summary
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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). Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes of CHD and self-administrated scale of Stable Angina Pectoris research on all indicators of CHD, and analyze their characteristics, target and function 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
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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.

Official Title
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Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example

Conditions
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Coronary Heart Disease, Stable Angina Pectoris

Intervention / Treatment
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* Drug: Louxiangdan Tongxin granules
* Drug: TCM granules placebo
* Drug: Chixiangshen Tongxin granules
* Drug: TCM granule placebo plus western basis treatment
* Drug: Western basis treatment


Participation Criteria
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Eligibility Criteria
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Inclusion criterion： The diagnosis standard according with stable angina coronary heart disease The participants with any one of the below six standards are included: history of myocardial infarction previously PCI postoperative patients CT showing more than 50% coronary stenosis Coronary angiography showing more than 50% coronary stenosis positive results of the electrocardiogram ischemia changes in the electrocardiogram recently The Patients with disease history more than three months, attacked in the recent one month Standard according to the phlegm and blood stasis syndrome or Qi deficiency and blood stasis syndrome of the traditional Chinese medicine Male: 45 years old < 75 years old Female: 50 years old < 75 years old Participants signed the agreement paper voluntarily. Exclusion criterion: Participants with Acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina), asymptomatic myocardial ischemia,ischemic cardiomyopathy,the myocardial infarction happening in the 3 months before the test Participants with rheumatism heart disease, hyper thyroid heart disease, hypertensive heart disease, myocarditis, cardiomyopathy Participants with Cervical disease, gallbladder cardiac syndrome, stomach and esophageal reflux, aortic dissection Participants with acute cerebral infarction and cerebral hemorrhage Participants with severe heart failure, lung function, liver function (AST, ALT 1.5 times normal standard), kidney function (BUN, Cr more than the normal standard), hematopoietic system and endocrine systems and serious primary disease, malignant tumor, gastrointestinal bleeding, gastric ulcer and are prone to bleed the Participants can not complete the whole test The serious high blood pressure and hard to control (SBP >= 180 mmHg or DBP >=110 mmHg) Participants of acute or chronic cardiac dysfunction with heart function III-IV Participants has been included in other clinical studies in one month; Participants with glaucoma Participants with Pregnancy Or Lactation ,Allergy Participants with mental disorder, or nervous disease, or illiteracy, or bad compliance for questionnaire

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phlegm and blood stasis Syndrome G<br> | Drug: Louxiangdan Tongxin granules<br>* 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.<br>* Other names: Louxiangdan Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd;Drug: Western basis treatment<br>* 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.<br>* Other names: Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation;|
| Placebo Comparator: Phlegm and blood stasis control G<br> | Drug: TCM granules placebo<br>* Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.<br>* Other names: TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd;Drug: Western basis treatment<br>* 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.<br>* Other names: Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation;|
| Experimental: Qi deficiency and blood stasis G<br> | Drug: Chixiangshen Tongxin granules<br>* 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.<br>* Other names: Chixiangshen Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd;Drug: Western basis treatment<br>* 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.<br>* Other names: Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation;|
| Placebo Comparator: Qi deficiency and blood stasis control G<br> | Drug: TCM granule placebo plus western basis treatment<br>* Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.<br>* Other names: TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd;Drug: Western basis treatment<br>* 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.<br>* Other names: Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed） |  | 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 |  | 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 |  | Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification |  | 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) |  | 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) |  | Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week | 
| Quality of life evaluative index: short form-12 (SF-12) |  | 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) |  | 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） |  | Taken at 2nd, 4th, 8th, 12th, 26th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical efficacy, 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), evaluative index