Efficacy and safety of FangJiHuangQi granule in patients with heart failure: a protocol of randomized, placebo-controlled trial

Background FangJiHuangQi Granules (FJHQG) is a Chinese patent medicine that alleviates heart failure (HF) symptoms derived from the formula FangJiHuangQi decoction. Previous experiment has revealed that FangJiHuangQi decoction alleviated pathological injury in rats with HF. This trial intends to evaluate FJHQG's efficacy and safety as a complementary therapy in addition to conventional drug treatment. Methods This trial is a randomized, double-blind, placebo-controlled study that recruits 100 patients with HF. Participants will be randomly assigned into the intervention and control groups ( n = 50 for each group). For a duration of 12 weeks, FJHQG will be administered to the intervention group, and the control group will receive standard therapy plus placebo. The primary outcome of the trial is the changes of six-minute walk test at week 24. Secondary outcomes include BNP levels, NYHA classification, major adverse cardiovascular events (MACE), and KCCQ quality of life scales. Other exploratory assessments at the beginning and after a 12-week period will include fluid balance, symptom score scales, echocardiograms, diuretic consumption, and biochemical indices. Monitoring of MACE will continue until 12 weeks after drug discontinuation. Discussion This study will evaluate the efficacy and safety of FJHQG in HF treatment and to examine potential mechanisms, offering new insights into HF treatment. Clinical Trial Registration ChiCTR.org , ChiCTR2400080029.