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Efficacy and Safety of Naoxueping in Non-Surgical Patients with Acute Intracerebral Hemorrhage

Efficacy and Safety of Naoxueping in Non-Surgical Patients with Acute Intracerebral Hemorrhage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126587
Enrollment
Unknown
Registered
2026-06-11
Start date
2026-06-24
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

Intracerebral Hemorrhage

Interventions

Experimental group:On the basis of standard treatment, Naoxueping is additionally administered (1 dose per day, divided into morning and evening doses, approximately 100?mL each time, for a treatment
control group:Standard treatment according to current guidelines

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Subjects shall meet all of the following criteria for inclusion: 1. Meet the above-mentioned diagnostic criteria for acute intracerebral hemorrhage, with first-onset non-surgical intracerebral hemorrhage; 2. The time from diagnosis to enrollment = 18 years old, with no restriction on gender; 4. The patient or their legal representative voluntarily participates in this study, signs the informed consent form, and is able to cooperate with all assessments and regular follow-ups; 5. The subject or their legal representative agrees to randomization and is willing to receive the treatment, examinations and follow-ups specified in the study protocol.

Exclusion criteria

Exclusion criteria: 1. Secondary intracerebral hemorrhage: hemorrhage caused by brain tumors (primary or metastatic), craniocerebral trauma, cerebrovascular malformations (arteriovenous malformations, cavernous hemangiomas, etc.), cerebral amyloid angiopathy, parasitic diseases, metabolic diseases, hematological diseases (e.g., hemophilia, immune thrombocytopenic purpura), or inappropriate use of anticoagulant/antiplatelet drugs. 2. Subarachnoid hemorrhage (SAH), primary intraventricular hemorrhage, or massive intraventricular hemorrhage due to hematoma rupture into the ventricular system. 3. Complicated with severe cardiac diseases (e.g., acute myocardial infarction, severe arrhythmia, cardiac insufficiency NYHA class ??), hepatic insufficiency (ALT or AST > 3 times the upper limit of normal), renal insufficiency (serum creatinine > 1.5 times the upper limit of normal), hematological diseases or druginduced coagulation disorders, or uncontrolled psychiatric disorders. 4. Known allergy to any component of Naoxueping (Moutan Cortex, Lycopi Herba, Rhei Radix et Rhizoma, Puerariae Radix, Luffae Fasciculus) or history of traditional Chinese medicine allergy. 5. Patients requiring emergency surgery or with planned surgery. 6. Pregnant or lactating women, or those with childbearing plans in the near future (within 6 months). 7. Patients with malignant tumors whose expected survival time is less than 3 months. 8. Participation in other clinical trials within the past 3 months. 9. Other conditions judged by the investigator to be inappropriate for participation in this study. 10. Patients with a modified Rankin Scale (mRS) score > 2 before the current onset; if the previous mRS score cannot be confirmed, it shall be comprehensively judged by the investigator based on previous functional status/care records.

Design outcomes

Primary

MeasureTime frame
hematoma absorption rate at 14+/-3 days;

Secondary

MeasureTime frame
Changes in hematoma volume at 14+/-3 days;mRS score;NIHSS score;hs-CRP level;ADL scale score;The rate of re-bleeding;

Countries

China

Contacts

Public ContactSong Juexian

Xuanwu Hospital Capital Medical University

songjuexian@vip.163.com+86 186 0138 8268

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026