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

Dongzhimen Hospital, Beijing

Status: Not yet enrolling

Conditions: Ischemic Stroke

Treatments: Drug: LongShengZhi capsule placebo; Drug: LongShengZhi capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05277311

HX-DZM-202119

Details and patient eligibility

About

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.

Enrollment: 1,376 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,376 participants in 2 patient groups, including a placebo group

LongShengZhi capsule

Experimental group

Description:

Experimental group

Treatment:

Drug: LongShengZhi capsule

LongShengZhi capsule placebo

Placebo Comparator group

Description:

Placebo group

Treatment:

Drug: LongShengZhi capsule placebo