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Clinical efficacy and mechanism of Kangxin formula granule on heart failure patients with Qi deficiency and blood stasis in vulnerable period

Clinical efficacy and mechanism of Kangxin formula granule on heart failure patients with Qi deficiency and blood stasis in vulnerable period

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069435
Enrollment
Unknown
Registered
2023-03-16
Start date
2023-03-31
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

heart failure

Interventions

treatment group:Kangxin formula granule + standard western medicine treatment
control group:Qili Qiangxin capsule + standard western medicine treatment

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the Western medical diagnostic criteria for chronic heart failure; 2. In line with the TCM diagnostic criteria of heart failure syndrome of Qi deficiency, blood stasis and water cessation; 3. Aged 18-80 years, both sexes; 4. Left ventricular ejection fraction (LVEF) <= 40% (modified Simpson's method); 5. NYHA cardiac function grade ?-? with stable clinical symptoms, including those diagnosed as grade ? within 2 weeks before enrollment; 6. Good compliance, can provide contact information, can accept regular interviews; 7. Participate voluntarily, understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Heart failure caused by valvular disease, congenital heart disease, pericardial disease, heart failure caused by liver, kidney and other important organ failure, heart failure caused by hyperthyroidism, anemia and other systemic diseases or heart failure with unknown etiology; 2. Uncontrollable malignant arrhythmias, sick sinus syndrome without pacemaker protection, or second degree type II + ATrioventricular block; 3. Patients who underwent coronary revascularization therapy or cardiac resynchronization therapy or had undergone cardiac resynchronization therapy within 1 month or planned within 3 months; 4. Patients with progressive exacerbation of acute coronary syndrome; 5. Iin patients with uncontrolled hypertension, systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg; 6. Cardiogenic shock patients; 7. Unrepaired valvular heart disease with left ventricular outflow tract obstruction, myocarditis, large aneurysm, dissecting aneurysm, and significant hemodynamic changes; 8. Patients with a history of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown classification) or lower extremity arterial disease in the past 6 months; 9. Patients with active bleeding disease in the past 6 months; 10. Patients with tumors, severe endocrine system diseases, mental diseases, severe liver and kidney primary diseases, and severe hematopoietic system primary diseases; 11. Patients who are pregnant, preparing for pregnancy, miscarriage, breastfeeding or after delivery during or within the last 6 months of pregnancy; 12. People with allergies or known allergies to treatment drugs; 13. Other ongoing clinical trials; 14. According to the judgment of the researcher, the study cannot be completed; 15. Life expectancy < 3 months.

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fraction, LVEF;

Secondary

MeasureTime frame
Left ventricular end-diastolic diameter, LVEDD;Left ventricular end-systolic diameter, LVESD;6-minute walk test;NT-proBNP;Heart function grade of New York Heart Association (NYHA);Minnesota Heart Failure Quality of Life Score;TCM syndrome integration;Cardiovascular death and rehospitalization for heart failure;

Countries

China

Contacts

Public ContactLi Rong

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

247571755@qq.com+86 13798184933

Outcome results

None listed

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