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Qifu Yixin Prescription in the treatment of heart failure with preserved ejection fraction: a randomized, double-blind, placebo-controlled study

Qifu Yixin Prescription in the treatment of heart failure with preserved ejection fraction: a randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088641
Enrollment
Unknown
Registered
2024-08-22
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Heart failure with preserved ejection fraction

Interventions

Control Group:Western medicine basic treatment + granules (2 times a day, 2 bags each time). Treatment for 3 months.
Experimental Group:Western medicine basic treatment + Qifu Yixin Prescription loading therapy (2 times a day, 2 bags each time). Treatment for 3 months.

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age range from 18 to 85 years old, regardless of gender. 2) Meets the diagnostic criteria for heart failure with preserved ejection fraction. 3) Patients who meet the diagnostic criteria for "Qi deficiency and blood stasis, or concurrent Yang deficiency, or concurrent Yin deficiency" in traditional Chinese medicine syndrome differentiation and classification. 4) NYHA cardiac function grading II-IV. 5) Those who voluntarily participate in the experiment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Implantation of a cardioverter defibrillator or implementation of cardiac resynchronization therapy within 12 weeks. 2) Concomitant acute coronary syndrome (within 30 days), cardiogenic shock, acute myocarditis, uncontrolled malignant arrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, severe valve disease requiring surgical treatment, and pulmonary embolism. 3) Patients with severe primary diseases such as heart, liver, kidney, hematopoiesis, and metabolic system, as well as malignant tumors, jaundice, and liver and kidney dysfunction. 4) Concomitant acute infected individuals. 5) Positive for human immunodeficiency virus (HIV) antibodies, positive for syphilis testing, and patients with hepatitis B and C. 6) Individuals with worsening heart failure symptoms caused by digitalis poisoning. 7) Planned pregnancy, pregnant or lactating women. 8) Suspected or confirmed alcohol or drug abusers. 9) Individuals with allergic constitution or allergic to two or more types of food or drugs, or allergic to experimental drugs and their raw materials and excipients. 10) Participate in other researchers within the past two months.

Design outcomes

Primary

MeasureTime frame
Cardiac function indicators;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Points;Evaluation of exercise tolerance;Evaluation of quality of life;End result;

Countries

China

Contacts

Public ContactYongming Liu

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

liuyongming@foxmail.com+86 137 0193 3617

Outcome results

None listed

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