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Naoxueshu oral liquid in patients with spontaneous intracerebral haemorrhage: a multicentre, randomised, placebo-controlled, double-blind trial

Naoxueshu oral liquid in patients with spontaneous intracerebral haemorrhage: a multicentre, randomised, placebo-controlled, double-blind trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074347
Enrollment
Unknown
Registered
2023-08-04
Start date
2023-08-05
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

cerebral hemorrhage

Interventions

study group:Naoxueshu oral solution 10ml, oral, tid
control group:Naoxueshu oral liquid mimetic agent 10ml, oral, tid

Sponsors

Beijing Tiantan Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? meet the diagnostic criteria of spontaneous intracerebral hemorrhage ? supratentorial intracerebral hemorrhage (bleeding volume 20ml-40ml) ? 18 years old = age =80 years old ? within 72 hours of onset ? 6 points = NIHSS score =25 points ? Glasgow Coma Scale (GCS) score =10 points ? patients or legal representatives gave informed consent and signed the informed consent form

Exclusion criteria

Exclusion criteria: ? Known to be allergic to Naoxueshu oral liquid or related drug ingredients ? previous history of stroke with modified Rankin scale (mRS) score =2 before the onset of the current stroke ? Previous history of lobar hemorrhage "(4) known causes of trauma, cerebral amyloid angiopathy, vascular malformation, aneurysm, coagulopathy, anticoagulation, or antiplatelet therapy. Drug therapy, thrombolytic therapy, cerebral infarction, hematologic disease, moyamoya disease, spontaneous or metastatic tumor, venous sinus thrombosis, "Cerebral hemorrhage due to vasculitis, pregnancy, or other definite causes. ? Primary intraventricular hemorrhage ? patients with active gastrointestinal ulcer or other definite rebleeding tendency ? Patients with severe heart, liver, kidney dysfunction, or other life-threatening diseases had a low expected survival time After 1 year ? Patients who have received or plan to undergo surgical treatment ? Pregnant, planning pregnancy, or breastfeeding women ? those currently participating in other interventional clinical trials

Design outcomes

Primary

MeasureTime frame
90-day functional prognosis;

Secondary

MeasureTime frame
90-d all-cause mortality;edema volume;NIHSS score;Self-reported outcome;90d mRS;life quality score;Pharmacoeconomic evaluation;

Countries

China

Contacts

Public ContactJu Yi

Beijing Tiantan Hospital affiliated to Capital Medical University

juyi1226@vip.163.com+86 136 4129 0235

Outcome results

None listed

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