Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Liaoning University of Traditional Chinese Medicine
• Collaborator: Ministry of Science and Technology of the People´s Republic of China
• Treatments: Aspirin; Atorvastatin; Atorvastatin Calcium

Criteria

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