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Registered study on the prevention and treatment of cerebral hemorrhage with Naoxueshu oral liquid

Registered study on the prevention and treatment of cerebral hemorrhage with Naoxueshu oral liquid

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074892
Enrollment
Unknown
Registered
2023-08-18
Start date
2023-04-22
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

cerebral hemorrhage

Interventions

Case series:N/A

Sponsors

Dongzhimen Hospital Affiliated of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old; (2) Meeting the diagnostic criteria for primary cerebral hemorrhage; (3) Within 7 days of onset; (4) Having taken Naoxueshu oral liquid; (5) Informed consent signed by the patient or his legal representative

Exclusion criteria

Exclusion criteria: (1) Known allergy to Naoxueshu oral liquid or related pharmaceutical ingredients. (2) Those who have a previous history of stroke and have residual sequelae that affect the outcome evaluation, i.e., the mRS score before the onset of this stroke is = 2 points. (3) Known to be caused by amyloid cerebrovascular disease, vascular malformations, aneurysms, coagulation disorders, after anticoagulant or antiplatelet drugs treatment, after thrombolytic therapy, post infarction bleeding transformation, hematological diseases, moyamoya disease, primary or metastatic tumors, cerebral hemorrhage caused by venous sinus thrombosis, vasculitis, pregnancy, and other clear causes. (4) Patients with subarachnoid hemorrhage and trauma. (5) Patients with active gastrointestinal ulcers or other clear tendency to rebleed. (6) Patients with severe liver or renal insufficiency (Note: Severe liver insufficiency is defined as ALT or AST greater than 3 times the normal upper limit; Severe renal insufficiency is defined as a blood creatinine value greater than 2 times the upper normal limit. (7) Those who suffer from other serious life-threatening diseases and have an expected survival time of less than 3 months. (8) Pregnant, planned, or lactating women. (9) Other diseases that significantly limit the evaluation of neurological function or affect patient follow-up. (10) Patients or their caregivers cannot cooperate in completing follow-up work.

Design outcomes

Primary

MeasureTime frame
Reduced volume and proportion of hematoma on the 14th day of onset (or discharge);New stroke events within 12 months of onset (ischemic stroke, hemorrhagic stroke);Proportion of independent living (mRS = 2) within 3 months of onset;Total expenses and treatment expenses during hospitalization;

Secondary

MeasureTime frame
Edema reduction volume on 7 and 14 days of onset (or at discharge);Improvement of neurological function defects (changes in NIHSS score at discharge compared to admission) and complications (incidence of deep vein thrombosis and pulmonary embolism) at 7 and 14 days of onset (or discharge);Proportion of patients with good living activity (BI = 90) within 3 months of onset;New combined vascular events (ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, or vascular death) within 3 months, 12 months ;;Cognitive function (MMSE score) within 3 months, 12 months of onset;The economic burden of disease from discharge to 3 months after onset;All-cause mortality within 12 months of onset;Adverse events and serious adverse event records;

Countries

China

Contacts

Public ContactKong Lingbo

Dongzhimen Hospital Affiliated of Beijing University of Chinese Medicine

klb1984@163.com+86 131 6732 3987

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026