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

ConditionsIntracerebral HemorrhageHypertension
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorGuangzhou University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: FTFY-919 Formula GranulesExperimental treatment 1 intervention
Group B: FTFY-919 Traditional DecoctionActive comparator 1 intervention
Group C: Placebo GranulesPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Utility-weighted modified Rankin Scale (uw-mRS) score at Day 90

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.

Time frame
Day 90 (± 7 days) after randomization

Secondary outcomes

1

National Institutes of Health Stroke Scale (NIHSS) score

Neurological deficit assessed by the National Institutes of Health Stroke Scale at Day 7 and Day 14; higher scores indicate more severe neurological impairment.

Time frame
Day 7 and Day 14 after randomization
2

Hematoma volume on head CT

Intracerebral hematoma volume measured by head CT using the multi-slice (Tada) formula at Day 7 and Day 14.

Time frame
Day 7 and Day 14 after randomization
3

Perihematomal edema volume on head CT

Perihematomal edema volume assessed by head CT at Day 7 and Day 14 after randomization.

Time frame
Day 7 and Day 14 after randomization
4

Death or severe disability (modified Rankin Scale 3-6) at Day 90

Proportion of participants with death or severe disability, defined as modified Rankin Scale score of 3 to 6, at Day 90.

Time frame
Day 90 after randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou University of Traditional Chinese Medicine

Lead sponsor

Guangdong Provincial Natural Science Foundation Management Committee

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov

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