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

Not Applicable

• Conditions: Ischemic Stroke
• Interventions: Drug: LongShengZhi capsule placebo; Drug: LongShengZhi capsule

• Registration Number: NCT05277311
• Lead Sponsor: Dongzhimen Hospital, Beijing

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study First Posted: 2022-03-14
• Last Update Posted: 2022-03-14
• Study Start: 2022-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1376

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LongShengZhi capsule placebo	LongShengZhi capsule placebo	Placebo group
LongShengZhi capsule	LongShengZhi capsule	Experimental group

Primary Outcome Measures

Name	Time	Method
The proportion of patients with excellent outcome	90 days after randomization	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).

Secondary Outcome Measures

Name	Time	Method
Distribution of the modified Rankin scale (mRS) scores	90 days after randomization	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.
The proportion of adverse events (AEs)	90 days after randomization	The proportion of AEs during the treatment.
The proportion of patients with good outcome	90 days after randomization	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).
Changes in Cognitive function	90 days after randomization	Cognitive function, as measured using the Montreal Cognitive Assessment (MoCA) score (range from 0 to 30, with less than 26 indicating cognitive impairment) change from baseline to 90 days after randomization.
Changes in National Institutes of Health Stroke Scale (NIHSS) scores	90 days after randomization	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.
The proportion of patients with poor quality of life	90 days after randomization	Poor quality of life defined as EuroQol Five Dimensions Questionnaire (EQ-D5) index score ≤0.5. The EQ-5D index score is measured on a scale of 0 (death) to 1 (full health).
The proportion of patients with functional independence	90 days after randomization	Functional independence measured withe BI, which was a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).
Changes in Motor function	90 days after randomization	Motor function, measured by the Fugl-Meyer Motor Scale (FMMS) score(range from 0-100, with lower score showing worse motor status) change from baseline to 90 days after randomization.