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Efficacy and Safety of NeuroprotectantCattle encephalon glycoside and ignotin injection for Intracerebral Cerebral Hemorrhage: a multicenter, randomized, double-blinded, placebo-controlled trial

Efficacy and Safety of NeuroprotectantCattle encephalon glycoside and ignotin injection for Intracerebral Cerebral Hemorrhage: a multicenter, randomized, double-blinded, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016620
Enrollment
Unknown
Registered
2018-06-12
Start date
2018-06-29
Completion date
Unknown
Last updated
2018-06-18

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

Conditions

Hypertensive intracerebral hemorrhage

Interventions

Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection:250ml, intravenous drip, q.d.
Placebo:250ml, intravenous drip, q.d.

Sponsors

The First Affiliated Hospital of PLA Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Individuals aged 18-75 years; 2. Newly diagnosed, untreated hypertensive intracerebral hemorrhage, bleeding position and volume were Basal ganglia and 25-50ml diagnosed by Head CT. The hemorrhage did not break into lateral ventricle; 3. Obvious neurological dysfunction after onset with no signs of cerebral hernia, GCS evaluation between 5-14, or NIHSS above 6, non-surgical treatment; 4. Recruit patients within 72 hours after onset, and CT examination shows no hematomas expansion in 6 hours and above after diagnostic CT (hematoma=5ml); 5. All patients gave written informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, moyamoya disease, cerebral arteritis, hematological diseases, metabolic disorders; 2. Patients whose hematoma is unstable or progress into intracranial hypertension syndrome; 3. Ever diagnosed with subarachnoid hemorrhage and ischemic cerebral infarction; 4. Ever received Anticoagulants or Antiplatelet drug treatment; 5. Abnormal coagulation function (platelet count 1.4); 6. Patients who need operation treatment (including external ventricular drainage); 7. Patients who may suffer from mental or physical diseases that interfere treatment evaluation; 8. Homocysteine determination value higher than 15µmol/L when admitted into hospital; 9. Patients who have serious diseases in heart, lung, liver, kidney, endocrine or hemopoietic system; 10. Allergic to protein or treatment medicine; 11. Drug or alcohol addiction; 12. Prospective pregnant women, women of childbearing age positive in pregnancy test or lactating women; 13. participated in other clinical trials within 3 months; k) patients considered not suitable for clinical trials by researchers.

Design outcomes

Primary

MeasureTime frame
Glasgow Outcome Scale - Extended (GOS-E);

Secondary

MeasureTime frame
Glasgow Outcome Scale - Extended (GOS-E);mRS evaluation;NIHSS scores;Barthel Index evaluation;DTI/FA?;SWI;Softening oven volume;rate of complication;

Countries

China

Contacts

Public ContactJin Hu

Huashan Hospital, Fudan University

yirui.sun@live.cn+86 021 52887732

Outcome results

None listed

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