Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index
NCT ID: NCT01502943
Last Updated: 2012-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
480 participants
INTERVENTIONAL
2011-05-31
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events
NCT01715376
Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.
NCT03171597
Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
NCT04022031
Traditional Chinese Medicine for Treatment of Chronic Heart Failure
NCT01939236
Study of Herbal Formula Corresponding to Syndrome in Treating Post Percutaneous Coronary Intervention (PCI) Patients With Coronary Heart Disease (CHD)
NCT00817024
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phlegm and blood stasis Syndrome G
Louxiangdan Tongxin granules
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.
Western basis treatment
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.
Phlegm and blood stasis control G
TCM granules placebo
Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.
Western basis treatment
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.
Qi deficiency and blood stasis G
Chixiangshen Tongxin granules
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.
Western basis treatment
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.
Qi deficiency and blood stasis control G
TCM granule placebo plus western basis treatment
Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.
Western basis treatment
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Louxiangdan Tongxin granules
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.
TCM granules placebo
Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.
Chixiangshen Tongxin granules
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.
TCM granule placebo plus western basis treatment
Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.
Western basis treatment
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 Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
45 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
Liaoning University of Traditional Chinese Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
YANG Guan-lin
Principal of Liaoning university of TCM
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guanlin Yang
Role: STUDY_CHAIR
Liaoning University of TCM
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009ZX09502-029
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.