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

Sponsor
Guangzhou University of Traditional Chinese Medicine
Study ID
NCT07801599
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Huayu Jiedu Formula (FTFY-919) Granules — DRUG
    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 — DRUG
    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 — DRUG
    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).

Study Details

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.

Key Dates

First listed
Sep 3, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Utility-weighted modified Rankin Scale (uw-mRS) score at Day 90 [ Time Frame: Day 90 (± 7 days) after randomization ]

Central Contacts

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