Intracerebral HemorrhagePhase 3CHAIN3NCT07801599

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

A Phase 3 study testing Huayu Jiedu Formula (FTFY-919) Granules and Huayu Jiedu Formula (FTFY-919) Traditional Decoction in people with Intracerebral Hemorrhage and Hypertension, run by Guangzhou University of Traditional Chinese Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Intracerebral Hemorrhage, Hypertension
What is being tested?: Huayu Jiedu Formula (FTFY-919) Granules and Huayu Jiedu Formula (FTFY-919) Traditional Decoction
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: No sites listed yet
Study dates: Sep 2026to Jan 2028
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;
Pregnancy or breastfeeding;
Participation in another clinical trial that may interfere with the evaluation of this trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jianwen Guo, MD contact

8613724899379

jianwen_guo@qq.com

About this study

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

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.

Read the detailed description

Hypertensive intracerebral hemorrhage (ICH) is a devastating subtype of stroke with high mortality and disability. Huayu Jiedu Formula (FTFY-919), a traditional Chinese medicine (TCM) formula composed of Radix Ginseng Rubra (30 g), Radix Notoginseng (30 g) and Radix et Rhizoma Rhei (5 g), has long been used in clinical practice for acute ICH. Whether the modern formula granules preparation is non-inferior to the traditional decoction has not been established in a rigorous trial.

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, non-inferiority trial. A total of 300 patients with acute hypertensive ICH will be randomly assigned in a 1:1:1 ratio to receive FTFY-919 formula granules, FTFY-919 traditional decoction, or placebo granules for 28 days, all in addition to standard Western medicine treatment. Randomization will be stratified by center and baseline hematoma volume. Granules, decoction-derived granules and placebo have identical appearance and packaging to maintain blinding of participants, care providers, investigators and outcome assessors.

The primary outcome is the utility-weighted modified Rankin Scale (uw-mRS) score at Day 90. The primary hypothesis is that FTFY-919 formula granules are non-inferior to the traditional decoction, with a non-inferiority margin of 0.2 in uw-mRS score; the placebo arm serves as an additional reference. Key secondary outcomes include neurological function, hematoma and perihematomal edema volumes, death or severe disability, health-related quality of life, TCM syndrome score, activities of daily living, recurrent or symptomatic ICH, and safety outcomes.

Follow-up visits are scheduled at Day 7, Day 14, Day 28 and Day 90 after randomization. Enrollment is planned to start in September 2026 at five centers in China, with primary completion anticipated in November 2027 and study completion in January 2028.

Conditions: Intracerebral Hemorrhage, Hypertension
Being tested: Huayu Jiedu Formula (FTFY-919) Granules, Huayu Jiedu Formula (FTFY-919) Traditional Decoction, Placebo Granules
Keywords: Huayu Jiedu Formula, Traditional Chinese Medicine, Formula Granules, Non-inferiority Trial
Medical subject headings: Cerebral Hemorrhage, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Huayu Jiedu Formula (FTFY-919) GranulesDrug
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 DecoctionDrug
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 GranulesDrug
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 groups in NCT07801599
Study group	Role	What they receive
FTFY-919 Formula Granules	Experimental	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. Receives: Drug: Huayu Jiedu Formula (FTFY-919) Granules
FTFY-919 Traditional Decoction	Active comparator	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. Receives: Drug: Huayu Jiedu Formula (FTFY-919) Traditional Decoction
Placebo Granules	Placebo comparator	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. Receives: Drug: Placebo Granules

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 90 (± 7 days) after randomization

Secondary outcomes (11)

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.
Measured: Day 7 and Day 14 after randomization
Hematoma volume on head CT
Intracerebral hematoma volume measured by head CT using the multi-slice (Tada) formula at Day 7 and Day 14.
Measured: Day 7 and Day 14 after randomization
Perihematomal edema volume on head CT
Perihematomal edema volume assessed by head CT at Day 7 and Day 14 after randomization.
Measured: Day 7 and Day 14 after randomization
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.
Measured: Day 90 after randomization
All-cause death at Day 90
All-cause mortality within 90 days after randomization.
Measured: Day 90 after randomization
Severe disability (modified Rankin Scale 3-5) at Day 90
Proportion of participants with severe disability, defined as modified Rankin Scale score of 3 to 5, at Day 90.
Measured: Day 90 after randomization
Health-related quality of life (EQ-5D-5L) at Day 90
European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L) questionnaire assessed at Day 90 to evaluate health-related quality of life.
Measured: Day 90 after randomization
Stroke Traditional Chinese Medicine (TCM) syndrome score
TCM syndrome score of stroke assessed using the stroke TCM syndrome scale at Day 14, Day 28 and Day 90; response classified as cured, markedly effective, effective or ineffective based on percentage reduction of the score.
Measured: Day 14, Day 28 and Day 90 after randomization
Barthel Index (activities of daily living) at Day 14 and Day 90
Barthel Index (ADL scale) assessed at Day 14 and Day 90; higher scores indicate better independence in activities of daily living.
Measured: Day 14 and Day 90 after randomization
Any recurrent intracerebral hemorrhage or symptomatic intracerebral hemorrhage
Occurrence of any recurrent intracerebral hemorrhage (ICH) or symptomatic ICH (sICH) during the 28-day treatment period.
Measured: During the 28-day treatment period
Adverse events, serious adverse events and adverse events of special interest
Safety assessed by adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI: hematoma expansion, new intracerebral hemorrhage, diarrhea, laboratory abnormalities including blood routine, liver and kidney function, coagulation, fecal occult blood and urinalysis) recorded up to Day 14.
Measured: Up to Day 14 after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Jan 2028

First posted3 Sep 2026
Study startSep 2026 (estimated)
Primary completionNov 2027 (estimated)
Study completionJan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Three-arm, 1:1:1 randomized trial: FTFY-919 formula granules, FTFY-919 traditional decoction, or placebo granules, in addition to standard Western medicine treatment.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07801599
Sponsor's protocol ID: 22202104030000378
Other IDs: SKLKY2025C0003
Acronym: CHAIN3
Status last verified: Aug 2026
First submitted: 30 Aug 2026
Last updated: 3 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Jianwen Guo, MD

8613724899379

jianwen_guo@qq.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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