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

NCT05277311 | Unknown DMC

• 1 other identifier: HX-DZM-202119
• Study Type: interventional
• Target: 1,376
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; LongShengZhi capsule; efficacy; safety; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Distribution of the modified Rankin scale (mRS) scores

  30 days after randomization

• Distribution of the modified Rankin scale (mRS) scores

  90 days after randomization

• The proportion of patients with good outcome

  30 days after randomization

• The proportion of patients with good outcome

  90 days after randomization

• Changes in National Institutes of Health Stroke Scale (NIHSS) scores

  90 days after randomization

Study Arms (2)

LongShengZhi capsule

EXPERIMENTAL

Experimental group

Drug: LongShengZhi capsule

LongShengZhi capsule placebo

PLACEBO COMPARATOR

Placebo group

Drug: LongShengZhi capsule placebo

Interventions

LongShengZhi capsule DRUG

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

LongShengZhi capsule

LongShengZhi capsule placebo DRUG

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

LongShengZhi capsule placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke patients within 7 days of onset
• years of age or older, and gender not limited
• NIHSS score of 4 to 15

You may not qualify if:

• 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

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

LongShengZhi

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Dandan Zhang, PhD, MD

CONTACT

+8618810532113; zx1zy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 14, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: March 14, 2022

Record last verified: 2022-03