Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example
Louxiangdan Tongxin granules
+ Western basis treatment
+ TCM granules placebo
Angina Pectoris+9
+ Cardiovascular Diseases
+ Chest Pain
Summary
Study start date: May 1, 2011
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.480 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 45 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboGroup III
ExperimentalGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Affiliated hospital of Changchun university of TCM
Changchun, ChinaOpen Affiliated hospital of Changchun university of TCM in Google MapsJilin integrative Chinese and western medicine hospital
Changchun, ChinaDalian integrative of Chinese and Western medicine hospital
Dalian, ChinaDandong TCM hospital
Dandong, China