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

Dongzhimen Hospital, Beijing1,376 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,376

Conditions

Ischemic Stroke

Interventions

LongShengZhi capsuleDRUG

LongShengZhi capsules, orally, 5 capsules each time, three times a day.

LongShengZhi capsule placeboDRUG

LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The proportion of patients with excellent outcome

Excellent outcome defined as a modified Rankin scale (mRS) score ≤ 1 (scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death).

Time frame: 90 days after randomization

Secondary Outcomes

Distribution of the modified Rankin scale (mRS) scores

Modified Rankin scale (mRS) scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death.

Time frame: 30 days after randomization

Distribution of the modified Rankin scale (mRS) scores

Modified Rankin scale (mRS) scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death.

Time frame: 90 days after randomization

The proportion of patients with good outcome

Good outcome defined as a modified Rankin scale (mRS) score ≤2(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death).

Time frame: 30 days after randomization

The proportion of patients with good outcome

Good outcome defined as a modified Rankin scale (mRS) score ≤2(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death).

Time frame: 90 days after randomization

Changes in National Institutes of Health Stroke Scale (NIHSS) scores

Difference of NIHSS scores (range =0-42, with higher scores indicating more severe strokes) between baseline and 30 days after randomization or 90 days after randomization.

Central Contacts

Dandan Zhang, PhD, MD

CONTACT

+8618810532113 zx1zy@126.com

Data from ClinicalTrials.gov

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