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Huayu Jiedu Formula (FTFY-919) Granules Versus Traditional Decoction for Acute Hypertensive Intracerebral Hemorrhage
Sponsor: Guangzhou University of Traditional Chinese Medicine
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-09
Completion Date
2028-01
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
Huayu Jiedu Formula (FTFY-919) 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.
Huayu Jiedu Formula (FTFY-919) Traditional Decoction
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
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).