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

NCT ID: NCT07200921

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 1950 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-10
• Study Completion Date: 2028-11-30

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.

Conditions

Hypertensive Intracerebral Hemorrhage; Cerebral Small Vessel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Group

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.

Group Type: EXPERIMENTAL

Naoxuekang Dropping Pills

Intervention Type: DRUG

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

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Naoxuekang Matching Placebo

Intervention Type: DRUG

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

Interventions

Naoxuekang Dropping Pills

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

Beijing Kangerfu Pharmaceutical Company Limited

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qian Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xintong Song, MD

Role: CONTACT

Songxt1962@163.com

010-17519241291

Facility Contacts

Qian Zhang, MD

Role: primary

goongchangqian@126.com

+86-010-5997-8585

Other Identifiers

2024ZD0522203

Identifier Type: -

Identifier Source: org_study_id