Status:
NOT_YET_RECRUITING
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensive Intracerebral Hemorrhage With Naoxuekang Dropping Pills
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
The Affiliated Hospital of Qingdao University
Beijing Kangerfu Pharmaceutical Company Limited
Conditions:
Hypertensive Intracerebral Hemorrhage
Cerebral Small Vessel Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
1950 Patients enrolled
Trial Details
Trial ID
NCT07200921
Start Date
October 10 2025
End Date
November 30 2028
Last Update
October 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070