Skip to content

Application of Berberine in the secondary prevention of ischaemic stoke: a multi-center, double-blind, randomized, placebo-controlled trial

Application of Berberine in the secondary prevention of ischaemic stoke: a multi-center, double-blind, randomized, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-PRC-09000494
Enrollment
Unknown
Registered
2009-08-04
Start date
2009-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

ischaemic stoke

Interventions

Group B:Berberine 0.5 g, orally taken three times daily and Atorvastatin 10mg once daily and Aspirine 0.1 g once daily for 1 year
Group P:Placebo 0.5 g, orally taken three times daily and Atorvastatin 10mg once daily and Aspirine 0.1 g once daily for 1 year

Sponsors

Second Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. male and female aged 35 to 75 years old; 2. patients with symptomatic cerebral infarction in the previous 2 weeks to 3 months; 3. patients with focal signs that had lasted >=24 hours and ischemic infarction-related focal lesion compatible with their signs and symptoms defined by computed tomography or magnetic resonance imaging; 4. patients provided written, informed consent; 5. patients with one or more risk factor for cerebrovascular disease that can be treated.

Exclusion criteria

Exclusion criteria: 1. patients with large area of cerebral infarction or ina coma; 2. patients with angioplasty of intra and exterior cerebral arterial stenosis; 3. women with pregnancy or lactation; 4. history of sensitivity to any of the medicine in the trial; 5. patients with cerebral infarction exception to atherosclerosis such as cardioembolic stroke, arteritis, polycythemia vera, crescent cell anaemia, thrombocythemia, purpura haemorrhagica, DIC, moyamoya disease, intracranial vascular malformation, intracranial aneurysm; 6. severe complication such as cardiac, renal, hepatic, lung or blood disorders or malignancy that can’t accomplish 1 year follow-up; current peptic ulceration; 7. psychiatric disease; 8. history of bleeding diathesis or systemic bleeding; 9. history of intracranial hemorrhage; 10. patients or their dependants disagree or reject to sign; 11. modified Rankin Scale(mRS) score of 4 or more; 12. water drinking test>=4; 13. enrollment<=3 months in any other clinical trial; 14. patients with G-6-PD; 15. judgment by investigators to be unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
Rate of cardiovascular events;Incidence of peripheral arteries diseases;Recurrence rate of stroke in 1 year;

Secondary

MeasureTime frame
Serum triglyceride and cholesterol, low density lipoprotein concentration;

Countries

China

Contacts

Public ContactYi Guo
yi_g4326@yahoo.com.cn+86 0755 25533018-3002

Outcome results

None listed

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