A Randomized, Double-Blind, Controlled, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of Huayu Jiedu Formula (FTFY-919) Granules Compared With Traditional Decoction in the Treatment of Patients With Acute Hypertensive Intracerebral Hemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Utility-weighted modified Rankin Scale (uw-mRS) score at Day 90
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators and outcome assessors are blinded. Granules, decoction-derived granules and placebo have identical appearance and packaging.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years;
- •Spontaneous intracerebral hemorrhage (ICH) confirmed by neuroimaging;
- •Hematoma volume 15-60 mL;
- •Within 48 hours of symptom onset (if onset time is unknown, the time last seen normal is used);
- •Meeting one of the following: basal ganglia or lobar hemorrhage with NIHSS score ≥ 8; or thalamic, brainstem or cerebellar hemorrhage with Glasgow Coma Scale (GCS) score 7-14;
- •Written informed consent obtained from the patient or the legal representative.
排除标准
- •ICH secondary to structural brain abnormalities (including but not limited to cerebral vascular malformation, intracranial aneurysm, malignant tumor, moyamoya disease, trauma and prior ischemic stroke), cerebral amyloid angiopathy, thrombolysis or thrombectomy, anticoagulant therapy, antiplatelet therapy, or other secondary causes;
- •Patients judged by the responsible physician unlikely to benefit from the trial (e.g., advanced dementia) or at very high risk of early death, or other conditions considered unsuitable by the investigator;
- •Conditions that may interfere with follow-up or outcome assessment (e.g., significant pre-stroke disability with modified Rankin Scale score 3-5, end-stage malignant tumor, renal failure);
- •Known contraindications to Chinese medicine;
- •Pregnancy or breastfeeding;
- •Participation in another clinical trial that may interfere with the evaluation of this trial.
研究组 & 干预措施
FTFY-919 Formula Granules
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.
干预措施: Huayu Jiedu Formula (FTFY-919) Granules (Drug)
FTFY-919 Traditional Decoction
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.
干预措施: Huayu Jiedu Formula (FTFY-919) Traditional Decoction (Drug)
Placebo Granules
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.
干预措施: Placebo Granules (Drug)
结局指标
主要结局
Utility-weighted modified Rankin Scale (uw-mRS) score at Day 90
时间窗: Day 90 (± 7 days) after randomization
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.
次要结局
- National Institutes of Health Stroke Scale (NIHSS) score(Day 7 and Day 14 after randomization)
- Hematoma volume on head CT(Day 7 and Day 14 after randomization)
- Perihematomal edema volume on head CT(Day 7 and Day 14 after randomization)
- Death or severe disability (modified Rankin Scale 3-6) at Day 90(Day 90 after randomization)
- All-cause death at Day 90(Day 90 after randomization)
- Severe disability (modified Rankin Scale 3-5) at Day 90(Day 90 after randomization)
- Health-related quality of life (EQ-5D-5L) at Day 90(Day 90 after randomization)
- Stroke Traditional Chinese Medicine (TCM) syndrome score(Day 14, Day 28 and Day 90 after randomization)
- Barthel Index (activities of daily living) at Day 14 and Day 90(Day 14 and Day 90 after randomization)
- Any recurrent intracerebral hemorrhage or symptomatic intracerebral hemorrhage(During the 28-day treatment period)
- Adverse events, serious adverse events and adverse events of special interest(Up to Day 14 after randomization)