Clinical trial NCT01502943: Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index
Official title: Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Stable Angina Pectoris
Keywords: Complementary Therapies
Traditional Chinese Medicine
Quality of life
Seattle angina questionnaire (SAQ)
SF-12
Measure Your Medical Outcome Profile (MYMOP)
Phlegm and blood stasis Syndrome
Qi deficiency and blood stasis Syndrome
Invigorating Spleen to Remove Phlegm or replenish Qi
Activating blood and dissolving stasis
Traditional Chinese medicine SYndrome Scale (TCMsys)
Patients Report Outcomes(PRO)
clinical efficacy
evaluative index
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2012-01-02
Enrollment: 480
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed）
timeFrame: Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
measure: New developed Quality of life evaluative index: patients report outcomes for SAP
timeFrame: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
measure: New developed Quality of life evaluative index: self-administrated scale of SAP
timeFrame: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week
Secondary outcomes:
measure: Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification
timeFrame: 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
measure: 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)
timeFrame: Taken at expected day 7 in the screening period (baseline) and Change from Baseline in 8th week
measure: Quality of life evaluative index: Seattle angina questionnaire (SAQ)
timeFrame: Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week
measure: Quality of life evaluative index: short form-12 (SF-12)
timeFrame: Taken at day 1 (baseline), Change from Baseline in 2nd, 4th, 8th, 12th week
measure: TCM characteristics evaluative index: Traditional Chinese medicine Syndrome Scale 2 (criteria)
timeFrame: Taken at expected day 7 in the Screening period,and Change from Baseline in 2nd,4th,8th week
measure: Endpoint index （Cardiovascular events, non-cardiovascular events, death, hospitalization due to coronary heart disease cases）
timeFrame: Taken at 2nd, 4th, 8th, 12th, 26th week
Other outcomes:
Locations:
city: Changchun
country: China
facility: Affiliated hospital of Changchun university of TCM
state: Jilin
city: Changchun
country: China
facility: Jilin integrative Chinese and western medicine hospital
state: Jilin
city: Dalian
country: China
facility: Dalian integrative of Chinese and Western medicine hospital
state: Liaoning
city: Dandong
country: China
facility: Dandong TCM hospital
state: Liaoning
city: Fuxin
country: China
facility: Fuxin TCM hospital
state: Liaoning
city: Shenyang
country: China
facility: Affiliated hospital of Liaoning university of TCM 2
state: Liaoning
city: Shenyang
country: China
facility: Affiliated hospital of Liaoning university of TCM
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Yingkou
country: China
facility: Yingkou TCM hospital
state: Liaoning
city: Tianjin
country: China
facility: Affiliated hospital of Tianjin university of TCM
state: Tianjin
Study officials:
affiliation: Liaoning University of TCM
name: Guanlin Yang
role: STUDY_CHAIR
References: