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

Primary Purpose

Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LongShengZhi capsule
LongShengZhi capsule placebo
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, LongShengZhi capsule, efficacy, safety, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    LongShengZhi capsule

    LongShengZhi capsule placebo

    Arm Description

    Experimental group

    Placebo group

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    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.
    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).
    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).
    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.
    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).
    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).
    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).
    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).
    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.
    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.
    The proportion of adverse events (AEs)
    The proportion of AEs during the treatment.

    Full Information

    First Posted
    February 8, 2022
    Last Updated
    March 9, 2022
    Sponsor
    Dongzhimen Hospital, Beijing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05277311
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dongzhimen Hospital, Beijing

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke
    Keywords
    ischemic stroke, LongShengZhi capsule, efficacy, safety, randomized controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1376 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LongShengZhi capsule
    Arm Type
    Experimental
    Arm Description
    Experimental group
    Arm Title
    LongShengZhi capsule placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo group
    Intervention Type
    Drug
    Intervention Name(s)
    LongShengZhi capsule
    Intervention Description
    LongShengZhi capsules, orally, 5 capsules each time, three times a day.
    Intervention Type
    Drug
    Intervention Name(s)
    LongShengZhi capsule placebo
    Intervention Description
    LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day.
    Primary Outcome Measure Information:
    Title
    The proportion of patients with excellent outcome
    Description
    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 Outcome Measure Information:
    Title
    Distribution of the modified Rankin scale (mRS) scores
    Description
    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
    Title
    Distribution of the modified Rankin scale (mRS) scores
    Description
    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
    Title
    The proportion of patients with good outcome
    Description
    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
    Title
    The proportion of patients with good outcome
    Description
    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
    Title
    Changes in National Institutes of Health Stroke Scale (NIHSS) scores
    Description
    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.
    Time Frame
    90 days after randomization
    Title
    The proportion of patients with poor quality of life
    Description
    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).
    Time Frame
    30 days after randomization
    Title
    The proportion of patients with poor quality of life
    Description
    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).
    Time Frame
    90 days after randomization
    Title
    The proportion of patients with functional independence
    Description
    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).
    Time Frame
    30 days after randomization
    Title
    The proportion of patients with functional independence
    Description
    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).
    Time Frame
    90 days after randomization
    Title
    Changes in Motor function
    Description
    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.
    Time Frame
    90 days after randomization
    Title
    Changes in Cognitive function
    Description
    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.
    Time Frame
    90 days after randomization
    Title
    The proportion of adverse events (AEs)
    Description
    The proportion of AEs during the treatment.
    Time Frame
    90 days after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dandan Zhang, PhD, MD
    Phone
    +8618810532113
    Email
    zx1zy@126.com

    12. IPD Sharing Statement

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

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