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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN): A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: LongShengZhi capsule
* Drug: LongShengZhi capsule placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LongShengZhi capsule<br>Experimental group | Drug: LongShengZhi capsule<br>* LongShengZhi capsules, orally, 5 capsules each time, three times a day.<br>|
| Placebo Comparator: LongShengZhi capsule placebo<br>Placebo group | Drug: LongShengZhi capsule placebo<br>* LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 90 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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). | 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. | 90 days after randomization | 
| The proportion of patients with poor quality of life | 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). | 30 days after randomization | 
| The proportion of patients with poor quality of life | 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). | 90 days after randomization | 
| The proportion of patients with functional independence | 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). | 30 days after randomization | 
| The proportion of patients with functional independence | 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). | 90 days after randomization | 
| Changes in Motor function | 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. | 90 days after randomization | 
| Changes in Cognitive function | 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. | 90 days after randomization | 
| The proportion of adverse events (AEs) | The proportion of AEs during the treatment. | 90 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, LongShengZhi capsule, efficacy, safety, randomized controlled trial