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A Prospective and Randomized Controlled Trial of Empirical Formula of Traditinal Chinease Medicine in Treating Chronic Heart Failure

A Prospective and Randomized Controlled Trial of Empirical Formula of Traditinal Chinease Medicine in Treating Chronic Heart Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049197
Enrollment
Unknown
Registered
2021-07-25
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Interventions

Sponsors

Chinese Academy of Medical Sciences Fuwai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients who meet the diagnostic criteria of Western medicine for coronary heart disease, elective patients within two weeks after DCB surgery; 3. Voluntary selection of patients who undergo coronary angiography 12 months after surgery; 4. Meet the TCM criteria for syndrome differentiation of Qi deficiency and blood stasis (total score >=8 points, and secondary symptoms >= 4 points); 5. The subjects voluntarily participated in the trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Heart valve disease, congenital heart disease, aortic dissection or aortic aneurysm requiring surgical or interventional treatment; 2. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, active myocarditis, infective endocarditis, constrictive pericarditis or other pericardial diseases; 3. Patients with malignant arrhythmia and poorly controlled hypertension; 4. Cardiac synchronization therapy within 3 months; cardiac PCI, CABG and other major vascular surgery or acute coronary syndrome within 1 month; 5. Cerebrovascular events such as old stroke and transient cerebral ischemia occurred within 6 months; 6. Patients with serious primary diseases and dysfunctions of the lung, liver, kidney, hematopoietic system, immune system, etc.; 7. Subjects who participated in other drug clinical trials or interventional studies within the first four weeks of this trial; 8. Patients with serious primary diseases and dysfunctions of the lung, liver, kidney, hematopoietic system, immune system, etc.; 9. Subjects who participated in other drug clinical trials or interventional studies within the first four weeks of this trial; 10. Those who are deemed unsuitable to participate in clinical trials by the investigator.

Design outcomes

Primary

MeasureTime frame
hospitalization for worsening heart failure;

Secondary

MeasureTime frame
all-cause mortality;hospitalization for cardiovascular events;NT-proBNP;New York Heart Association cardiac function;left ventricular ejection fraction;Six-Minute Walk Distance;Minnesota heart failure quality of life scale;Hospital Anxiety and Depression Scale;Quantization Table for Traditional Chinese Medicine Syndrome Differentiation;blood routine;

Countries

China

Contacts

Public ContactMa Lihong

Chinese Academy of Medical Sciences Fuwai Hospital

mlh8168@163.com+86 18601902828

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026