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NCT07801599Not yet recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
300 (estimated)
First submitted
30 Aug 2026
Start date
Sept 2026
Primary completion date
Nov 2027
Lead sponsor
Guangzhou University of Traditional Chinese Medicine
NCT number
NCT07801599

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 300
  • From Sept 2026 to the primary completion date, Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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);

Other

  • Known contraindications to Chinese medicine;
  • Pregnancy or breastfeeding;
  • Participation in another clinical trial that may interfere with the evaluation of this trial.

Who the study is looking for

  • 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.

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.