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

NCT07200921 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2024ZD0522203
• Study Type: interventional
• Target: 1,950
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Composite Vascular Events

  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).

  Within 1 year after the onset of intracerebral hemorrhage.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Drug: Naoxuekang Dropping Pills

Control Group

PLACEBO COMPARATOR

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.

Drug: Naoxuekang Matching Placebo

Interventions

Naoxuekang Dropping Pills DRUG

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

Experimental Group

Naoxuekang Matching Placebo 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• The Affiliated Hospital of Qingdao University: collaborator
• Beijing Kangerfu Pharmaceutical Company Limited: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive; Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qian Zhang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xintong Song, MD

CONTACT

010-17519241291; Songxt1962@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-08

Locations

CN (1)