Huayu Jiedu Formula (FTFY-919) Granules Versus Traditional Decoction for Acute Hypertensive Intracerebral Hemorrhage

Hypertensive intracerebral hemorrhage (ICH) is a devastating subtype of stroke with high mortality and disability. Huayu Jiedu Formula (FTFY-919), a traditional Chinese medicine (TCM) formula composed of Radix Ginseng Rubra (30 g), Radix Notoginseng (30 g) and Radix et Rhizoma Rhei (5 g), has long been used in clinical practice for acute ICH. Whether the modern formula granules preparation is non-inferior to the traditional decoction has not been established in a rigorous trial. This is a multicenter, randomized, double-blind, parallel, placebo-controlled, non-inferiority trial. A total of 300 patients with acute hypertensive ICH will be randomly assigned in a 1:1:1 ratio to receive FTFY-919 formula granules, FTFY-919 traditional decoction, or placebo granules for 28 days, all in addition to standard Western medicine treatment. Randomization will be stratified by center and baseline hematoma volume. Granules, decoction-derived granules and placebo have identical appearance and packaging to maintain blinding of participants, care providers, investigators and outcome assessors. The primary outcome is the utility-weighted modified Rankin Scale (uw-mRS) score at Day 90. The primary hypothesis is that FTFY-919 formula granules are non-inferior to the traditional decoction, with a non-inferiority margin of 0.2 in uw-mRS score; the placebo arm serves as an additional reference. Key secondary outcomes include neurological function, hematoma and perihematomal edema volumes, death or severe disability, health-related quality of life, TCM syndrome score, activities of daily living, recurrent or symptomatic ICH, and safety outcomes. Follow-up visits are scheduled at Day 7, Day 14, Day 28 and Day 90 after randomization. Enrollment is planned to start in September 2026 at five centers in China, with primary completion anticipated in November 2027 and study completion in January 2028.