Clinical trial NCT05277311: Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN)
Official title: Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN): A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: ischemic stroke
LongShengZhi capsule
efficacy
safety
randomized controlled trial
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 1376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The proportion of patients with excellent outcome
timeFrame: 90 days after randomization
Secondary outcomes:
measure: Distribution of the modified Rankin scale (mRS) scores
timeFrame: 30 days after randomization
measure: Distribution of the modified Rankin scale (mRS) scores
timeFrame: 90 days after randomization
measure: The proportion of patients with good outcome
timeFrame: 30 days after randomization
measure: The proportion of patients with good outcome
timeFrame: 90 days after randomization
measure: Changes in National Institutes of Health Stroke Scale (NIHSS) scores
timeFrame: 90 days after randomization
measure: The proportion of patients with poor quality of life
timeFrame: 30 days after randomization
measure: The proportion of patients with poor quality of life
timeFrame: 90 days after randomization
measure: The proportion of patients with functional independence
timeFrame: 30 days after randomization
measure: The proportion of patients with functional independence
timeFrame: 90 days after randomization
measure: Changes in Motor function
timeFrame: 90 days after randomization
measure: Changes in Cognitive function
timeFrame: 90 days after randomization
measure: The proportion of adverse events (AEs)
timeFrame: 90 days after randomization
Other outcomes:
Locations:
Study officials:
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