Intracranial Hemorrhage, Hypertensive
Conditions
Brief summary
This multicenter, prospective, double-blind, randomized controlled trial will enroll 902 non-surgical patients with supratentorial hypertensive intracerebral hemorrhage who meet the traditional Chinese medicine syndrome criteria of Qi deficiency with blood stasis and toxin-induced injury to the brain collaterals. The primary efficacy endpoint is the proportion of patients achieving a favorable outcome, defined as a modified Rankin Scale score of 0-2 at 180 days after treatment. Participants will be allocated across three trial regions: South China, Northeast China, and East China, with target enrollments of 400, 300, and 202 patients, respectively. Using a central randomization system, patients will be stratified by study center, hematoma volume, and severity of neurological deficit, and randomized 1:1 to the experimental group or control group. The experimental group will receive Yiqi Huayu Jiedu Mixture, composed of red ginseng, Panax notoginseng, and raw rhubarb, while the control group will receive a matching placebo. Both interventions will be administered for 28 days, in addition to standardized conventional Western medical treatment. Clinical and imaging data will be collected at multiple time points throughout the study. The primary outcome is the favorable prognosis rate at 180 days. Secondary outcomes include neurological function, quality of life, hematoma and perihematomal edema volume, and other relevant indicators. Adverse events will be monitored to evaluate the safety and efficacy of the mixture in reducing mortality and disability among patients with hypertensive intracerebral hemorrhage.
Interventions
DRUGYiqi Huayu Jiedu Mixture Intervention
Yiqi Huayu Jiedu Mixture, composed of red ginseng, Panax notoginseng, and raw rhubarb
DRUGThe placebo
The placebo is matched to the Yiqi Huayu Jiedu mixture in terms of outer packaging, appearance, odor, taste, and other identifiable characteristics to ensure blinding.
Sponsors
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Participants will be randomly assigned in a parallel manner to 2 arms: an experimental group and a placebo control group. This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Adults aged 18 years or older, with no restriction on sex. 2.6 to 48 hours after symptom onset; if the exact onset time cannot be determined, the time shall be calculated from the last known well. 3.Patients meeting the traditional Chinese medicine syndrome criteria of "Qi deficiency, blood stasis, and toxin-induced injury to the brain collaterals." Diagnosis shall be based on the Expert Consensus on Integrated Traditional Chinese and Western Medicine for Cerebral Hemorrhage (T/CAIM 023-2021) issued by the Chinese Association of Integrative Medicine. 4.Imaging-confirmed supratentorial hypertensive intracerebral hemorrhage (HICH) located in the basal ganglia, thalamus, lobar region, or subcortical white matter, with a hematoma volume of 15-60 mL. 5.NIHSS score ≥ 8 and GCS score \> 7. 6.The patient or the patient's legally authorized representative has provided written informed consent
Exclusion criteria
Patients meeting \*\*one or more\*\* of the following criteria will be excluded: 1. Intracerebral hemorrhage secondary to structural brain abnormalities, including but not limited to cerebral vascular malformation, intracranial aneurysm, malignant tumor, moyamoya disease, trauma, previous ischemic stroke, cerebral amyloid angiopathy, thrombolysis or thrombectomy, anticoagulant therapy, or other causes of secondary intracerebral hemorrhage. 2. Patients who, in the judgment of the treating physician, are unlikely to benefit from the trial, have an extremely high risk of early death, or are considered unsuitable for participation by the investigator, such as patients with advanced dementia. 3. Conditions that may interfere with follow-up or outcome assessment, such as known significant pre-stroke disability, modified Rankin Scale score of 3-5, end-stage malignancy, or renal failure. 4. Indications for decompressive craniectomy, including but not limited to coma or progressive deterioration of consciousness, large hematoma with significant midline shift, intracranial hypertension difficult to control with medical treatment, cerebral herniation or impending herniation, or marked mass effect on imaging, such as midline shift \>10 mm or compression/disappearance of cisterns or sulci. 5. Known allergy to any traditional Chinese medicine component of the mixture. 6. Pregnant or lactating women. 7. Participation in another clinical trial that may interfere with the evaluation of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the favorable prognosis rate | at 180 days | mRS 0-2 |
Secondary
| Measure | Time frame |
|---|---|
| Ordinal mRS outcome data | at 28, 90, and 180 days |
| NIHSS scores | at 7, 14, and 28 days |
| EQ-5D-5L scores | at 28, 90, and 180 days |
| Hematoma volume and perihematomal edema volume | at 7 days, 14 days, or discharge. |
| GCS score | at days 7, 14, and 28 |
Contacts
CONTACTLijin Huang, Professor
Outcome results
None listed