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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: LongShengZhi capsule; Drug: LongShengZhi capsule placebo

• Study Type: Interventional
• Enrollment (Anticipated): 1376
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dandan Zhang, PhD, MD; Phone Number: +8618810532113; Email: zx1zy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LongShengZhi capsule; Experimental group	Drug: LongShengZhi capsule; LongShengZhi capsules, orally, 5 capsules each time, three times a day.
PLACEBO_COMPARATOR: LongShengZhi capsule placebo; Placebo group	Drug: LongShengZhi capsule placebo; LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (ACTUAL): March 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; safety; efficacy; ischemic stroke; LongShengZhi capsule
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: HX-DZM-202119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No