Coronary Heart Disease Clinical Trial
Official title:
Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example
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.
Status | Completed |
Enrollment | 480 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
China | 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 | Shenyang | Liaoning |
China | Affiliated hospital of Liaoning university of TCM 2 | Shenyang | Liaoning |
China | Shengjing Hospital of China Medical University | Shenyang | Liaoning |
China | Affiliated hospital of Tianjin university of TCM | Tianjin | Tianjin |
China | Yingkou TCM hospital | Yingkou | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Liaoning University of Traditional Chinese Medicine | Ministry of Science and Technology of the People´s Republic of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Primary | 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 | No | |
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | Yes | |
Secondary | Quality of life evaluative index: Seattle angina questionnaire (SAQ) | Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week | No | |
Secondary | Quality of life evaluative index: short form-12 (SF-12) | Taken at day 1 (baseline), Change from Baseline in 2nd, 4th, 8th, 12th week | No | |
Secondary | 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 | No | |
Secondary | Endpoint index (Cardiovascular events, non-cardiovascular events, death, hospitalization due to coronary heart disease cases) | Taken at 2nd, 4th, 8th, 12th, 26th week | No |
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