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

NCT07801599 | Not Yet Recruiting Phase 3

• 2 other identifiers: 22202104030000378SKLKY2025C0003
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intracerebral Hemorrhage; Hypertension

Keywords

Huayu Jiedu Formula; Traditional Chinese Medicine; Formula Granules; Non-inferiority Trial

Outcome Measures

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.

  Day 90 (± 7 days) after randomization

Secondary Outcomes (11)

• National Institutes of Health Stroke Scale (NIHSS) score

  Day 7 and Day 14 after randomization

• Hematoma volume on head CT

  Day 7 and Day 14 after randomization

• Perihematomal edema volume on head CT

  Day 7 and Day 14 after randomization

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

  Day 90 after randomization

• All-cause death at Day 90

  Day 90 after randomization

Study Arms (3)

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.

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.

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.

Drug: Placebo Granules

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.

FTFY-919 Formula Granules

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).

Placebo Granules

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.

FTFY-919 Traditional Decoction

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• Guangdong Provincial Natural Science Foundation Management Committee: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Cerebral Hemorrhage; Hypertension

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianwen Guo, MD

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianwen Guo, MD

CONTACT

8613724899379; jianwen_guo@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators and outcome assessors are blinded. Granules, decoction-derived granules and placebo have identical appearance and packaging.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share