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

Study acronym: CHAIN3
StatusNot Yet Recruiting
PhasePhase 3
Started2026-09
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07801599
Lead Sponsor Guangzhou University of Traditional Chinese Medicine
Collaborators: Guangdong Provincial Natural Science Foundation Management Committee, Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions Intracerebral Hemorrhage, Hypertension
Enrollment 300 participants
Start Date 2026-09
Primary Completion 2027-11 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-03