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A randomized, double-blind, parallel-controlled, multi-center clinical trial for Guanxinshutong capsule in the treatment of heart failure caused by coronary disease with ejection fraction decrease

Evidence-based optimization and therapeutic mechanism of traditional Chinese medicine prevention and treatment plan for coronary disease (angina pectoris-myocardial infarction-heart failure)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023877
Enrollment
Unknown
Registered
2019-06-15
Start date
2019-06-30
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

Coronary heart disease with ejection fraction decreased heart failure

Interventions

Experimental group:Guan-Xin Shu-Tong Capsule, Oral 3 capsules once, 3 times a day, for 12 weeks
Control group:Guanxin Shutong Capsule Simulator, Oral, 3 capsules once, 3 times a day, for 12 weeks

Sponsors

the Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. meet the diagnosis of coronary disease and chronic ejection fraction decline heart failure; 2. meet the TCM syndrome diagnostic criteria of blood stasis syndrome; 3. Aged 40 to 80 years male and female; 4. screening NYHA heart function II and III period; 5. left ventricular ejection fraction (LVEF) <50% (by two-dimensional echocardiographic Simpson method); 6. the course of disease = 3 months, and the condition is stable within the recent 1 month, the standardized treatment is more than 1 month and the dose is stable; 7. plasma NT-proBNP=125ng/L; 8. volunteer, understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. acute coronary syndrome (ACS) occurred in the past 1 month; 2. those who require cardiac surgery in the past 3 months or during the trial; 3. cardiogenic shock, acute myocarditis, uncontrollable malignant arrhythmia, hypertrophic obstructive cardiomyopathy, severe valvular disease requiring surgery and pulmonary embolism; 4. uncontrolled hypertension (systolic blood pressure =180mmHg, diastolic blood pressure >110mmHg) or hypotension (resting blood pressure) <90/50mmHg; 5. patients with severe liver and kidney dysfunction and patients with active liver disease, and / or AST, ALT = 3 times the upper limit of normal; 6. psychiatric patients, or patients with severe depression, a history of alcohol or drug abuse; 7. pregnant women, lactating women and those who are preparing to give birth during the period of taking the medicine or within 3 months after stopping the medicine; 8. allergic or those who have been allergic to multiple drugs or who are allergic to the ingredients in the study; 9. patients with a history of cancer or existing cancer, or pathological examination confirmed precancerous lesions; 10. those who participated in other clinical studies 3 months before the trial, and other patients who considered it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
6min walking distance test (6MWT) improvement value;

Secondary

MeasureTime frame
NT-proBNP content change;NYHA heart function classification;Minnesota Heart Failure Quality of Life Scale (MLHFQ);Echocardiography;TCM syndrome improvement;Compound endpoint event rate;

Countries

China

Contacts

Public ContactHaitong Wan

Zhejiang University of Traditional Chinese Medicine

whtong@126.com+86 13606614920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026