A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensive Intracerebral Hemorrhage With Naoxuekang Dropping Pills

Phase 2Not Yet RecruitingNCT07200921

Beijing Tiantan Hospital1,950 enrolled

Overview

This study aims to evaluate the effectiveness and safety of a Chinese medicine-based intervention combined with standard medicine, in reducing composite vascular events in patients with hypertensive intracerebral hemorrhage (HICH).This is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 1950 participants with HICH within 7 days of onset, accompanied by imaging evidence of cerebral small vessel disease, will be enrolled.Participants will be randomly assigned to receive eitherNaoxuekang Dropping Pills or matching placebo for 90 days, in addition to guideline-based standard care.The primary outcome is the incidence of composite vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death, deep vein thrombosis, and pulmonary embolism) within 1 year.Secondary outcomes include vascular events within 90 days, neurological function (mRS), and cognitive function (MMSE, MoCA) at 90 days and 1 year.Safety will be monitored through adverse event reporting.The results will provide evidence for optimizing secondary prevention strategies in HICH patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,950

Conditions

Hypertensive Intracerebral Hemorrhage Cerebral Small Vessel Diseases

Interventions

Naoxuekang Dropping PillsDRUG

A traditional Chinese medicine. Each pill weighs 35mg. Dosage: 20 pills, three times daily, orally for 90 days.

Naoxuekang Matching PlaceboDRUG

A placebo pill matched to Naoxuekang Dropping Pills in appearance, taste , size, and packaging. Dosage: 20 pills, three times daily, orally for 90 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Meets the diagnostic criteria for hypertensive intracerebral hemorrhage. 2. Able to cooperate with a head MRI examination and has imaging manifestations of cerebral small vessel disease (CSVD) (Staals total CSVD burden score ≥ 1). 3. Supratentorial hemorrhage (volume ≤ 30ml) or infratentorial hemorrhage (volume ≤ 10ml). 4. Within 7 days of symptom onset. 5. NIHSS score ≤ 25. 6. GCS score ≥ 8. 7. Age between 18 and 80 years (inclusive). 8. Any gender Exclusion Criteria: 1. Primary intraventricular hemorrhage. 2. Spontaneous intracerebral hemorrhage due to other causes or secondary intracerebral hemorrhage (e.g., from trauma, vascular malformations, coagulation disorders, hematological diseases, systemic diseases, or tumors). 3. Planned surgical intervention (including craniotomy for hematoma evacuation, minimally invasive hematoma removal, or ventricular puncture). 4. Patients with active peptic ulcer, bleeding, or other clear tendency for rebleeding. 5. Patients with severe hepatic or renal dysfunction (Severe hepatic dysfunction: ALT or AST \> 3 times the upper limit of normal; Severe renal dysfunction: Serum creatinine \> 2 times the upper limit of normal). 6. Suffering from other life-threatening severe diseases with an expected survival time of less than 1 year. 7. Known allergy to any component of the study drug. 8. Pregnant women, women planning pregnancy, or lactating women. 9. Participating in another interventional clinical trial.

Outcomes

Primary Outcomes

Incidence of Composite Vascular Events

Composite vascular events within one year of onset, including arterial vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death) and venous vascular events (lower extremity venous thrombosis, pulmonary embolism).

Time frame: Within 1 year after the onset of intracerebral hemorrhage.