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

Capital Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Hypertensive Intracerebral Hemorrhage; Cerebral Small Vessel Diseases

Treatments: Drug: Naoxuekang Matching Placebo; Drug: Naoxuekang Dropping Pills

Study type: Interventional

Funder types: Other

Identifiers

NCT07200921

2024ZD0522203

Details and patient eligibility

About

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.

Enrollment: 1,950 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,950 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

Participants in this group will receive Naoxuekang Dropping Pills (20 pills, three times daily) orally for 90 days, in addition to standardized guideline-based Western medical care.

Treatment:

Drug: Naoxuekang Dropping Pills

Control Group

Placebo Comparator group

Description:

Participants in this group will receive matched placebo pills (20 pills, three times daily) orally for 90 days, in addition to standardized guideline-based Western medical care.

Treatment:

Drug: Naoxuekang Matching Placebo