Completed

Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example

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What is being tested

Louxiangdan Tongxin granules

+ Western basis treatment

+ TCM granules placebo

Drug
Who is being recruted

Angina Pectoris+9

+ Cardiovascular Diseases

+ Chest Pain

From 45 to 75 Years
See all eligibility criteria
How is the trial designed

Placebo-ControlledPhase 4
Interventional
Study Start: May 2011
See protocol details

Summary

Principal SponsorLiaoning University of Traditional Chinese Medicine
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleStudies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example
NCT01502943
Principal SponsorLiaoning University of Traditional Chinese Medicine
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

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.
Conditions
Criteria

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

Angina PectorisCardiovascular DiseasesChest PainCoronary DiseaseHeart DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaAngina, Stable

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.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Group III

Experimental

Group IV

Placebo

Study 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

Suspended

Affiliated hospital of Changchun university of TCM

Changchun, ChinaOpen Affiliated hospital of Changchun university of TCM in Google Maps
Suspended

Jilin integrative Chinese and western medicine hospital

Changchun, China
Suspended

Dalian integrative of Chinese and Western medicine hospital

Dalian, China
Suspended

Dandong TCM hospital

Dandong, China
Completed10 Study Centers