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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03018769
Other study ID # FirstTeachingHTianjinUTCM
Secondary ID
Status Recruiting
Phase N/A
First received January 7, 2017
Last updated January 12, 2017
Start date December 2016
Est. completion date December 2017

Study information

Verified date January 2017
Source First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Contact bi mr yingfei, doctor
Phone 022-27432327
Email yingfei1981@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1.1 To build a TCM diagnosis and treatment database for chronic stable CAD; 1.2 To summarize the pattern of TCM medicine used and the effect of the medication in chronic stable CAD.

1.3 To formulate a syndrome differentiation determined medicine plan based on the improvement in the quality of life on chronic stable CAD patients.


Description:

Chronic stable coronary artery disease (SCAD) is a general term for all kinds of coronary artery disease (CAD) which includes patients with chronic stable angina, oldmyocardial infarctions and also stable condition after revascularization (i.e percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)). According to 2012 American Heart Association/American College of Cardiology (AHA/ACC) guide, the objective of the treatment for SCAD is to maintain or recover patients' exercise tolerance, quality of life and avoid complication like heart failure,so as to decrease mortality, eliminate symptoms and avoid adverse reactions.

Traditional Chinese medicine (TCM) has two thousand years of history in managing CAD and has its advantages in improving quality of life. Using scientific method to evaluate, demonstrate and conclude the clinical curative effect of TCM is an extremely important task for both TCM and Chinese and western integrative medicine win the treatment of CAD. Recent researches mainly focus on certain types or some certain pathological and physiological stages of CAD, worse still, different areas experts have their own experiences and opinions with the treatment. There is a lack of unified syndrome differentiation and prescriptions plan for the chronic stable CAD and not enough attention has been paid to TCM despite it having many advantages in improving quality of life in these patients. Considering all the above, this research studied past syndromes research results and real clinical effective chronic SCAD cases. Cases were analysed and explored, effective cases were filtered, syndrome differentiation of the prescriptions was refined, thus build a TCM diagnosis and treatment information database.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- without age limit

- diagnose as chronic SCAD at first visit

- heart function classification between II~III Canada classification(CCS)

- Be willing to accept Chinese herbal decoction

- sign an informed consent

Exclusion Criteria:

- suffer from acute myocardial infarction (AMI) ,unstable angina or prior revascularization(i.e PCI,CABG) in the latest 60 days .

- have such diseases as follow: a.poorly controlled blood pressure even taken medicine(systolic pressure=180mmHg, diastolic pressure=100mmHg); - severe arrhythmia(atrial fibrillation with rapid ventricular response, atrial flutter, paroxysmal ventricular tachycardia, etc); c.pulmonary heart disease, rheumatic heart disease, myocarditis, cardiomyopathy, aortic dissection, pulmonary embolism.

- hyperthyreosis, cervical spondylosis, gallbladder-cardiac syndrome, gastroesophageal reflux, esophageal hiatal hernia, neurosis, climacteric syndrome and other diseases which would cause chest pain.

- alanine transaminase(ALT) or serum creatinine(Scr) more than twice the normal reference value.

- hemoglobin(Hb)<100g/L or have severe hematological system disease.

- malignant tumor.

- pregnant, lactating women or other women have reproductive requirement.

- psychosis or cognition impairment person.

- taken chinese medicine decoction in recent two weeks.

- not take part in any other clinical trail.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chinese Herb


Locations

Country Name City State
China The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine Anhui
China Beijing Hospital of Traditional Chinese Medicine Beijing
China Dongfang Hospital of Beijing University of Chinese Medicine Beijing
China Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine Beijing
China Guang'anmen Hospital of China Academy of Chinese Medical Sciences Beijing
China the third Affiliated to Beijing University of Chinese Medicine Beijing
China Xiyuan Hospital of China Academy of Chinese Medical Sciences Beijing
China Affiliated Hospital of Changchun University of Traditional Chinese Medicine Changchun
China Affiliated Hospital of Gansu University of Chinese Medicine Gansu
China Guangdong Provincial Hospital of Chinese Medicine Guangdong
China Guangdong Second Troditional Chinese Medicine Hospital Guangdong
China First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Guangzhou
China Heilongjiang Provincial Hospital of traditional Chinese Medicine Heilongjiang
China Henan Province Hospital of TCM Henan
China The First Affiliated Hospital of Henan University of TCM Henan
China Affiliated Hospital of Hunan Academy of Chinese Medicine Hunan
China The First Hospital of Hunan University of Chinese Medicine Hunan
China The Second Affiliated Traditional hospital of Hunan University of Traditional Chinese Medicine Hunan
China Jiangsu Province Hospital of TCM Jiangsu
China Jiangxi Provincial Hospital of Chinese Medicine Jiangxi
China Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Liaoning
China The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine Liaoning
China Shandong Province Hospital of Traditional Chinese Medicine Shandong
China Shanxi Hospital of Traditional Chinese Medicine Shanxi
China Shanxi Province Hospital of Traditional Chinese Medicine Shanxi
China The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine Shanxi
China The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medcine Shanxi
China Shijiazhuang Traditional Chinese Medicine Hospita Shijiazhuang
China First Teaching Hospital of Tianjin University of TCM Tianjin
China Second Affiliated Hospital of Tianjin University of TCM Tianjin
China Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital Tianjin
China Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region Xinjiang

Sponsors (1)

Lead Sponsor Collaborator
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary EuroQol-5 Dimensions (EQ-5D) change from take chinese herb in one week
Primary Four diagnostic method of TCM change from take chinese herb in one week
Primary electrocardiograms(ECG) change from take chinese herb in one week
Primary dynamic electrocardiogram change from take chinese herb in one week
Primary ultrasonic cardiogram change from take chinese herb in one week
Primary treadmill exercise testing (TET) change from take chinese herb in one week