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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phlegm and blood stasis Syndrome G | Experimental |
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| Phlegm and blood stasis control G | Placebo Comparator |
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| Qi deficiency and blood stasis G | Experimental |
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| Qi deficiency and blood stasis control G | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Louxiangdan Tongxin granules | Drug | 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. |
| 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 |
| 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) |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Guanlin Yang | Liaoning University of TCM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Changchun university of TCM | Changchun | Jilin | 110000 | China | ||
| Jilin integrative Chinese and western medicine hospital |
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| TCM granules placebo | Drug | Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper. |
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| Chixiangshen Tongxin granules | Drug | 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. |
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| TCM granule placebo plus western basis treatment | Drug | Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper. |
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| Western basis treatment | Drug | 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. |
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| 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 |
| Changchun |
| Jilin |
| 110000 |
| China |
| Dalian integrative of Chinese and Western medicine hospital | Dalian | Liaoning | 110000 | China |
| Dandong TCM hospital | Dandong | Liaoning | 110000 | China |
| Fuxin TCM hospital | Fuxin | Liaoning | 110000 | China |
| Affiliated hospital of Liaoning university of TCM 2 | Shenyang | Liaoning | 110000 | China |
| Affiliated hospital of Liaoning university of TCM | Shenyang | Liaoning | 110000 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110000 | China |
| Yingkou TCM hospital | Yingkou | Liaoning | 110000 | China |
| Affiliated hospital of Tianjin university of TCM | Tianjin | Tianjin Municipality | 110000 | China |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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