Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN)

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to determine if LongShengZhi Capsule is effective and safe in patients with ischemic stroke in comparison to placebo. This trial is a prospective, multicenter, randomized, placebo-controlled, double-blinded, parallel-group, superiority trial.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongzhimen Hospital, Beijing

Criteria

Inclusion Criteria:

• Acute ischemic stroke patients within 7 days of onset

• 18 years of age or older, and gender not limited

• NIHSS score of 4 to 15

Exclusion Criteria:

• Secondary stroke caused by a tumor, traumatic brain injury, hematological disease, or other diseases with a confirmed diagnosis

• Pre-stroke mRS score of more than 1

• Known severe liver or kidney dysfunction

• Known allergies for ingredients in the investigational product

• Known bleeding diathesis or coagulation disorder

• Known medical condition likely to limit survival to less than 3 months

• Pregnant women (clinically evident) or breastfeeding women

• Participation in any investigational study in the previous 3 months

• Known dementia, uncontrolled psychiatric problems

• Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator