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

NCT ID: NCT05277311

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LongShengZhi capsule

Experimental group

Group Type EXPERIMENTAL

LongShengZhi capsule

Intervention Type DRUG

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

LongShengZhi capsule placebo

Placebo group

Group Type PLACEBO_COMPARATOR

LongShengZhi capsule placebo

Intervention Type DRUG

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

Interventions

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LongShengZhi capsule

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

Intervention Type DRUG

LongShengZhi capsule placebo

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Dandan Zhang, PhD, MD

Role: CONTACT

+8618810532113

Other Identifiers

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HX-DZM-202119

Identifier Type: -

Identifier Source: org_study_id

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