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Clinical study of Xinbao pill in the treatment of chronic heart failure (CHF) with deficiencysyndrome of heart and kidney yang

Xinbao pills in the treatment of CHF with deficiency syndrome of heart and kidney yang: a multicenter, randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038492
Enrollment
Unknown
Registered
2020-09-23
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Chronic Heart Failure (CHF)

Interventions

Sponsors

Shunde Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of chronic heart failure, and TCM syndrome differentiation is heart kidney yang deficiency syndrome; 2. The patients aged 18 years = 450 pg / ml; 6. Patients who have received standardized drug treatment for at least 2 weeks and have not adjusted the dosage; 7. Patients who voluntarily participate in the study understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with heart failure due to valvular disease, congenital heart disease, pericardial disease, arrhythmia and non cardiogenic causes, or heart failure caused by liver and kidney and other important organ failure; and right heart failure and acute heart failure caused by definite pulmonary or other reasons; 2. Patients who plan to undergo coronary revascularization therapy or cardiac resynchronization therapy in the near future, and those who have implemented cardiac resynchronization therapy; 3. In patients with severe primary diseases such as liver, kidney and hematopoietic system, liver transaminase and alkaline phosphatase exceeded the upper limit of 3 times of normal value, serum creatinine > 2mg / dl (176.82 umol/L), and serum potassium > 5.5mmol/l; in patients with tumor, severe neuroendocrine system diseases and psychosis; in patients with severe neuroendocrine system diseases, serum creatinine > 2mg / dl (176.82umol/L), serum potassium > 5.5mmol/l; 4. Patients with left ventricular outflow tract obstruction, myocarditis, large aneurysms, dissecting aneurysms, unrepaired valvular heart disease with obvious hemodynamic changes; 5. Patients with cardiogenic shock, uncontrollable malignant arrhythmia, progressive unstable angina pectoris or acute myocardial infarction; 6. Patients with uncontrolled hypertension, systolic blood pressure >= 180 / mmHg and / or diastolic blood pressure >= 110 mmHg; 7. At the same time in the use of other cardiotonic or diuretic drugs, such as salbutamol, etc.; 8. Patients who participated in the clinical study of other drugs within one month; 9. Women who are pregnant or are preparing for pregnancy and lactation; 10. Objects of allergic constitution or known allergic to therapeutic drugs; 11. Patients with Yin deficiency and internal heat, hyperactivity of liver Yang and phlegm fire in TCM syndrome differentiation; 12. Patients with glaucoma; 13. According to the investigator's judgment, the patient could not complete the study or could not comply with the requirements of this study (due to management reasons or other reasons).

Design outcomes

Primary

MeasureTime frame
The proportion of patients whose serum NT-proBNP decreased more than 30%;

Secondary

MeasureTime frame
NYHA cardiac function classification;6 min walking distance test;Minnesota quality of life scale for heart failure;Cardiovascular composite endpoints, including cardiovascular death and readmission due to heart failure;NT??;Cardiac ultrasound;Curative effect of TCM Syndrome;

Countries

China

Contacts

Public ContactWang Dawei

Shunde Hospital of Guangzhou University of Chinese Medicine (Shunde District Hospital of Chinese Medicine of Foshan City)

13902236233@139.com+86 13902236233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026