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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07200921

Acronym

TCM-ICH

Enrollment

1950

Registered

2025-10-01

Start date

2025-10-10

Completion date

2028-11-30

Last updated

2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Small Vessel Diseases, Hypertensive Intracerebral Hemorrhage

Keywords

Hypertensive intracerebral hemorrhage, Cerebral small vessel disease, Naoxuekang Dropping Pills, Randomized controlled trial

Brief summary

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.

Interventions

DRUGNaoxuekang Dropping Pills

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

DRUGNaoxuekang Matching Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Participants are randomly assigned to one of two parallel groups: the Naoxuekang group or the placebo control group.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Composite Vascular Events	Within 1 year after the onset of intracerebral hemorrhage.	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).

Countries

China

Contacts

Primary ContactXintong Song, MD

Songxt1962@163.com010-17519241291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026