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Clinical study on the efficacy and safety of Qiangxin Bushen Decoction in the treatment of patients with heart failure combined with renal insufficiency and heart kidney yang deficiency syndrome

Clinical study on the efficacy and safety of Qiangxin Bushen Decoction in the treatment of patients with heart failure combined with renal insufficiency and heart kidney yang deficiency syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000281
Enrollment
Unknown
Registered
2024-08-21
Start date
2024-04-28
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Chronic heart failure with renal insufficiency

Interventions

Qiangxin Bushen Decoction group:Qiangxin Bushen Decoction + Basic western medicine treatment

Sponsors

Shanghai Putuo District Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: a. Older than 18 years old, regardless of gender; b. Left ventricular ejection fraction (LVEF) < 50%; c. According to the diagnostic criteria of chronic heart failure, NYHA cardiac function classification ? ~ ?, no history of acute attack within 3 months, stable condition; Have chest tightness / shortness of breath / fatigue / sweating / edema and other symptoms; d. Renal function decreased, 30ml / (min • 1.73m2) < EGFR < 90ml / (min • 1.73m2); e. Those who meet the syndrome differentiation criteria of heart kidney yang deficiency in traditional Chinese medicine; f. The subjects must give informed consent to the trial before the trial, sign the informed consent voluntarily, and be able to follow the doctor's advice to complete the study. Only those who meet the above 6 items can be included in this study.

Exclusion criteria

Exclusion criteria: a. Patients who are ready for heart transplantation or cardiac resynchronization therapy (CRT); b. Patients with acute pulmonary edema or acute hemodynamic disorders; c. Patients with strict fluid intake limit of no more than 500ml/ day; d. Female patients who have or plan to become pregnant; e. Patients with severe liver function impairment; f. The investigator judged that the survival time was no more than 3 months; g. According to the judgment of the investigator, the patient could not complete the study or comply with the requirements of the study. Patients who meet any of the above conditions shall be excluded.

Design outcomes

Primary

MeasureTime frame
Six-minute walk distance;

Secondary

MeasureTime frame
NT-proBNP;Minnesota heart failure quality of life questionnaire;TCM symptom score;sST2;SCr;Left ventricular ejection fraction;Urinary microalbumin / creatinine ratio;eGFR;low density lipoprotein;SDS self rating Depression Scale;SAS self rating Anxiety Scale;Microalbuminuria;FS;BUN;

Countries

China

Contacts

Public ContactZongjun Liu

Shanghai Putuo District Center Hospital

liuzongjun1548@shutcm.edu.cn+86 198 2157 7439

Outcome results

None listed

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