What is the clinical evidence from this study?

Study design: RCT. Population: Heart failure (n=100). Intervention: FangJiHuangQi granule vs. Placebo. Primary outcome: Change in 6-minute walk test distance at week 24.

May 29, 2026Open Access

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

Key Result

FangJiHuangQi granule will be evaluated against placebo for its ability to improve six-minute walk test distance at 24 weeks in 100 patients with stable heart failure.

Study Design

Type

RCT (n=100)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Structured PICO

Does FangJiHuangQi granule improve 6-minute walk test distance in patients with heart failure?

Population

A planned randomized controlled trial of 100 adult patients aged 18 to 80 years with stable chronic heart failure (LVEF ≥ 41%) and NYHA class II-III, followed for 24 weeks.

Intervention

FangJiHuangQi granule (FJHQG) 5 g oral twice daily added to conventional drug therapy for 12 weeks

Comparator

Matching placebo added to conventional drug therapy for 12 weeks

Outcome

Changes in six-minute walk test at week 24surrogate

This study protocol outlines a randomized controlled trial to evaluate the efficacy and safety of FangJiHuangQi granule as an add-on therapy for improving exercise capacity in patients with heart failure.

Limitations

Limited timeframe of the study resulting in a short follow-up period
Exclusion of participants with heart failure aged over 80
Assumed effect size may be relatively optimistic
Study population will consist predominantly of Han Chinese individuals from southern China

Abstract

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.

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