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Not yet recruiting NCT07200921

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

Phase II Interventional Hypertensive Intracerebral Hemorrhage Cerebral Small Vessel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Naoxuekang Dropping Pills, Naoxuekang Matching Placebo.
Who it may be relevant to
Registry conditions: Hypertensive Intracerebral Hemorrhage, Cerebral Small Vessel Diseases. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Interventions

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

Primary outcome measures

  • Incidence of Composite Vascular Events [Time frame: Within 1 year after the onset of intracerebral hemorrhage.]

Eligibility criteria

Inclusion criteria

  • Meets the diagnostic criteria for hypertensive intracerebral hemorrhage.
  • Able to cooperate with a head MRI examination and has imaging manifestations of cerebral small vessel disease (CSVD) (Staals total CSVD burden score ≥ 1).
  • Supratentorial hemorrhage (volume ≤ 30ml) or infratentorial hemorrhage (volume ≤ 10ml).
  • Within 7 days of symptom onset.
  • NIHSS score ≤ 25.
  • GCS score ≥ 8.
  • Age between 18 and 80 years (inclusive).
  • Any gender

Exclusion criteria

  • Primary intraventricular hemorrhage.
  • 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).
  • Planned surgical intervention (including craniotomy for hematoma evacuation, minimally invasive hematoma removal, or ventricular puncture).
  • Patients with active peptic ulcer, bleeding, or other clear tendency for rebleeding.
  • 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).
  • Suffering from other life-threatening severe diseases with an expected survival time of less than 1 year.
  • Known allergy to any component of the study drug.
  • Pregnant women, women planning pregnancy, or lactating women.
  • Participating in another interventional clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07200921 · 2024ZD0522203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗