Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

Liaoning University of Traditional Chinese Medicine

Status and phase: Completed; Phase 4

Conditions: Coronary Heart Disease; Stable Angina Pectoris

Treatments: Drug: TCM granule placebo plus western basis treatment; Drug: Louxiangdan Tongxin granules; Drug: Chixiangshen Tongxin granules; Drug: Western basis treatment; Drug: TCM granules placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01502943

2009ZX09502-029

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 480 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

480 participants in 4 patient groups, including a placebo group

Phlegm and blood stasis Syndrome G

Experimental group

Treatment:

Drug: Western basis treatment

Drug: Louxiangdan Tongxin granules

Phlegm and blood stasis control G

Placebo Comparator group

Treatment:

Drug: TCM granules placebo

Drug: Western basis treatment

Qi deficiency and blood stasis G

Experimental group

Treatment:

Drug: Western basis treatment

Drug: Chixiangshen Tongxin granules

Qi deficiency and blood stasis control G

Placebo Comparator group

Treatment:

Drug: Western basis treatment

Drug: TCM granule placebo plus western basis treatment