A Phase 3 interventional study of Huayu Jiedu Formula (FTFY-919) Granules and Huayu Jiedu Formula (FTFY-919) Traditional Decoction in Intracerebral Hemorrhage and Hypertension, sponsored by Guangzhou University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Guangzhou University of Traditional Chinese Medicine · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, double-blind, controlled, non-inferiority clinical trial to evaluate the efficacy and safety of Huayu Jiedu Formula (FTFY-919) Chinese medicine formula granules compared with traditional decoction in patients with acute hypertensive intracerebral hemorrhage (ICH). A total of 300 eligible patients will be randomized in a 1:1:1 ratio to receive FTFY-919 formula granules, FTFY-919 traditional decoction, or placebo granules for 28 days, in addition to standard western medicine treatment. The primary outcome is the utility-weighted modified Rankin Scale (mRS) score at Day 90. Secondary outcomes include NIHSS score, hematoma volume and perihematomal edema volume, death or severe disability, EQ-5D-5L, Barthel Index and TCM syndrome scores. The trial will be conducted at 5 centers in China.
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.
Exclusion Criteria:
Huayu Jiedu Formula (FTFY-919) formula granules: Radix Ginseng Rubra 30 g, Radix Notoginseng 30 g, Radix et Rhizoma Rhei 5 g. 14.5 g per sachet, one sachet three times daily for 28 days, started within 48 hours of ICH onset, dissolved in 100 mL warm water, administered orally or via nasogastric tube. In addition to standard Western medicine treatment.
Drug: Huayu Jiedu Formula (FTFY-919) Granules
Traditional decoction of Huayu Jiedu Formula (FTFY-919): Radix Ginseng Rubra 30 g (concentrated decoction), Radix Notoginseng 30 g (15 g concentrated decoction plus 15 g powder), Radix et Rhizoma Rhei 5 g (powder). Decoction concentrated into granules with identical appearance and packaging; same dosage and regimen as the formula granules (14.5 g three times daily for 28 days). In addition to standard Western medicine treatment.
Drug: Huayu Jiedu Formula (FTFY-919) Traditional Decoction
Placebo granules prepared from non-bioactive food additives in accordance with the T/CACM 1420-2022 standard for Chinese medicine placebo simulation. Identical appearance, packaging, dosage and regimen to the active treatment (14.5 g three times daily for 28 days). In addition to standard Western medicine treatment.
Drug: Placebo Granules
Huayu Jiedu Formula (FTFY-919) Chinese medicine formula granules containing Radix Ginseng Rubra 30 g, Radix Notoginseng 30 g and Radix et Rhizoma Rhei 5 g per dose. 14.5 g per sachet, one sachet three times daily for 28 consecutive days, first dose within 48 hours of symptom onset, dissolved in 100 mL warm water, administered orally or via nasogastric tube. Manufactured by Guangdong Yifang Pharmaceutical Co., Ltd.
Traditional decoction of Huayu Jiedu Formula (FTFY-919) containing Radix Ginseng Rubra 30 g (concentrated decoction), Radix Notoginseng 30 g (15 g concentrated decoction plus 15 g powder) and Radix et Rhizoma Rhei 5 g (powder) per dose. Decoction is concentrated into granules with identical appearance and packaging to the formula granules; same dosage and regimen (14.5 g three times daily for 28 days). Manufactured by Guangdong Yifang Pharmaceutical Co., Ltd.
Placebo granules prepared from non-bioactive food additives in accordance with the T/CACM 1420-2022 standard for placebo simulation of Chinese patent medicines. Identical appearance, packaging, dosage and regimen to the active treatment (14.5 g three times daily for 28 days).
Utility-weighted modified Rankin Scale (uw-mRS) score at Day 90
Modified Rankin Scale assessed at Day 90, converted to utility-weighted scores (weights: mRS 0 = 1.0, 1 = 0.91, 2 = 0.76, 3 = 0.65, 4 = 0.33, 5 = 0, 6 = 0). Primary comparison: FTFY-919 formula granules versus traditional decoction (non-inferiority, margin 0.2); placebo arm serves as an additional reference.
Time frame: Day 90 (± 7 days) after randomization
National Institutes of Health Stroke Scale (NIHSS) score
Neurological deficit assessed by the National Institutes of Health Stroke Scale at Day 7 and Day 14; higher scores indicate more severe neurological impairment.
Time frame: Day 7 and Day 14 after randomization
Hematoma volume on head CT
Intracerebral hematoma volume measured by head CT using the multi-slice (Tada) formula at Day 7 and Day 14.
Time frame: Day 7 and Day 14 after randomization
Perihematomal edema volume on head CT
Perihematomal edema volume assessed by head CT at Day 7 and Day 14 after randomization.
Time frame: Day 7 and Day 14 after randomization
Death or severe disability (modified Rankin Scale 3-6) at Day 90
Proportion of participants with death or severe disability, defined as modified Rankin Scale score of 3 to 6, at Day 90.
Time frame: Day 90 after randomization
All-cause death at Day 90
All-cause mortality within 90 days after randomization.
Time frame: Day 90 after randomization
Severe disability (modified Rankin Scale 3-5) at Day 90
Proportion of participants with severe disability, defined as modified Rankin Scale score of 3 to 5, at Day 90.
Time frame: Day 90 after randomization
Health-related quality of life (EQ-5D-5L) at Day 90
European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire assessed at Day 90 to evaluate health-related quality of life.
Time frame: Day 90 after randomization
Stroke Traditional Chinese Medicine (TCM) syndrome score
TCM syndrome score of stroke assessed using the stroke TCM syndrome scale at Day 14, Day 28 and Day 90; response classified as cured, markedly effective, effective or ineffective based on percentage reduction of the score.
Time frame: Day 14, Day 28 and Day 90 after randomization
Barthel Index (activities of daily living) at Day 14 and Day 90
Barthel Index (ADL scale) assessed at Day 14 and Day 90; higher scores indicate better independence in activities of daily living.
Time frame: Day 14 and Day 90 after randomization
Any recurrent intracerebral hemorrhage or symptomatic intracerebral hemorrhage
Occurrence of any recurrent intracerebral hemorrhage (ICH) or symptomatic ICH (sICH) during the 28-day treatment period.
Time frame: During the 28-day treatment period
Adverse events, serious adverse events and adverse events of special interest
Safety assessed by adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI: hematoma expansion, new intracerebral hemorrhage, diarrhea, laboratory abnormalities including blood routine, liver and kidney function, coagulation, fecal occult blood and urinalysis) recorded up to Day 14.
Time frame: Up to Day 14 after randomization
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Plan to share: No
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Guangzhou University of Traditional Chinese Medicine