Effect and Safety of Xinfuli Granules in Chronic Heart Failure with Qi Deficiency and Blood Stasis: A Single-Center Randomized Controlled Trial

Chin J Integr Med. 2025 Oct 23. doi: 10.1007/s11655-025-4022-7. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the clinical effect and safety of Xinfuli Granules (, XFLG) in improving patients with heart failure (HF) of qi deficiency and blood stasis syndrome.

METHODS: In this singlecenter randomized controlled trial, HF patients were randomized (1:1) to either the XFLG group (178 cases) or the control group (178 cases). Patients in the control group received standard HF therapy. In addition, patients in the XFLG group were administered XFLG (10 g, 3 times daily) for 12 weeks. The primary outcomes observed were the composite of all-cause mortality and HF-related hospitalization; and secondary outcomes included changes in left ventricular ejection fraction (LVEF), N-terminal pro-brain natriuretic peptide (NT-pro BNP), New York Heart Association (NYHA) functional class, Minnesota Living with Heart Failure Questionnaire (MLHFQ) score, Chinese medicine (CM) syndrome score, Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder-7 (GAD-7) scores.

RESULTS: After 12 weeks, the XFLG group demonstrated a significantly lower incidence of the primary endpoint compared to the control group (hazard ratio, 0.566; 95% confidence interval: 0.325-0.988; P<0.05). Besides, the XFLG group showed greater improvements in LVEF and NT-pro BNP reduction (P<0.05 or P<0.01). Compared with the control group, the total effective rate of NYHA functional class and CM syndrome was significantly higher; the MLHFQ, PHQ-9, and GAD-7 scores were significantly lower in the XFLG group (P<0.05 or P<0.01).

CONCLUSIONS: XFLG combined with standard HF therapy significantly reduced the risk of all-cause mortality and HF-related hospitalization composite events, improved cardiac function, and quality of life, alleviated depressive and anxiety states in HF patients, with a favorable safety profile. These results support XFLG as a promising adjunctive treatment for HF with qi deficiency and blood stasis. (Registration No. ChiCTR2100049197).

PMID:41129050 | DOI:10.1007/s11655-025-4022-7