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A multicenter randomized double-blind placebo-controlled study on the application of plasma proteome to analyze the therapeutic mechanism and drug sensitivity prediction of ShenYu Yangxin Capsule in the treatment of chronic heart failure

A multicenter randomized double-blind placebo-controlled study of the treatment of chronic heart failure with Zhiyu Yangxin capsules and a proteomics-based analysis of the mechanism of action and drug sensitivity prediction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001287
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

chronic heart failure

Interventions

treatment group :Conventional Western medicine treatment + Shen Yu Yangxin capsules
Health group:nonintervention

Sponsors

Southwest Medical University Affiliated Hospital of Traditional Chinese Medicine Longmatan District Luzhou City Sichuan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Treatment group vs. control group: 1) Chronic heart failure is diagnosed according to the Chinese Heart Failure Treatment Guidelines 2018; heart function grade II-III according to the American College of Cardiology (NYHA); 2) Deficiency of vital energy syndrome based on the reference of "Expert Consensus on Diagnosis and Treatment of Chronic Heart Failure in Traditional Chinese Medicine"; 3) Age of onset: 40 years old to 70 years old; 4) The patient and/or authorized agent give informed consent and sign the informed consent form. Healthy control group: 1) No clinical symptoms echocardiography and BNP showed no heart failure or other organic heart disease; 2) Age: 40 years old to 70 years old; 3) The patient and/or authorized agent give informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who do not meet the inclusion criteria; 2) The combination has severe liver and kidney dysfunction; 3) Pregnant and lactating women patients with allergic constitution and history of mental illness; 4) Acute myocardial infarction unstable angina; congenital heart disease; valvular heart disease; myocardial infarction in the last 2 months; patients who have been implanted with pacemakers and coronary and other stents that are not suitable for MRI materials; 5) Patients with malignant tumors; 6) Participants in other clinical trials; 7) Researchers identified patients who were not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Cardiac color Doppler ultrasound stroke volume (SV), left ventricular systolic and end-diastolic volume index (LVESV1, LVEDV1), left ventricular ejection fraction (LVEF);Heart function classification (NYHA);Change value of total effective rate of heart failure in western medicine;Chinese medicine syndrome element score;BNP;

Secondary

MeasureTime frame
Six minutes' walk away;Minnesota Heart Failure Quality of Life Score;

Countries

China

Contacts

Public ContactLuo Gang

Southwest Medical University Affiliated Hospital of Traditional Chinese Medicine

1831008305@qq.com13679678969

Outcome results

None listed

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