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Camphorine hydrobromide injection in the treatment of acute ischemic stroke: a prospective randomized open-label multicenter clinical study

Camphorine hydrobromide injection in the treatment of acute ischemic stroke: a prospective randomized open-label multicenter clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044939
Enrollment
Unknown
Registered
2021-03-31
Start date
2021-04-05
Completion date
Unknown
Last updated
2021-11-02

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

Conditions

Acute anterior circulation cerebral infarction within 1 week of onset

Interventions

Treatment group:Anisodine Hydrobromide Injection 2mg qd Intravenous drip, a total of 7-10 days
Control group:Treatment is given in accordance with the 2018 Chinese Guidelines for ischemic Stroke

Sponsors

General Hospital of PLA North Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 18 years and above, regardless of gender; 2.Ischemic stroke within 1 week of onset; 3.Patients with anterior circulation cerebral infarction; 4.First onset, or previous stroke but mRS<=11 before onset; 5.The degree of neurological impairment (NIHSS) score ranged from 5 to 20; 6.Understand and sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1.Patients receiving intravenous thrombolysis or mechanical thrombolysis; 2.Severe consciousness disorder (NIHSS score Ia>=2 points); 3.Cranial imaging examination confirmed that there are similar symptoms such as brain tumor encephalitis brain abscess, or confirmed that there are hemorrhagic cerebral infarction and so on; 4.A person with a serious heart disease, serious arrhythmia, or heart failure; 5.Severe abnormal liver and kidney function (laboratory indicator of liver function ALT> 1.5 ULN, laboratory indicator of kidney function Cr> 1.5 ULN); 6.Patients with a history of mental illness or dementia; 7.Associated with malignancy of any organ or system, or undergoing antitumor therapy, expected survival <3 months; 8.Significant drug or alcohol abuse; 9.Allergic constitution and allergy to two or more drugs or food; Or is known to be allergic to this drug ingredient; 10.A woman who is already pregnant and has a pregnancy plan or is breast-feeding; 11.Participated in other clinical trials in the past 3 months; 12.The investigators determined that the patients were not eligible for the study.

Design outcomes

Primary

MeasureTime frame
Randomize the proportion of good prognosis (mRS 0-2) at 90 days;

Secondary

MeasureTime frame
MRS score of 90 days after onset;Percentage of mRS 0-1 patients 90 days after onset;NIHSS score for 14 days of medication;The 90-day all-cause mortality rate;Incidence of combined vascular events at 90 days;

Countries

China

Contacts

Public ContactChen Huisheng
350039577@qq.com+86 13352452086

Outcome results

None listed

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