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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05277311
• Other study ID #: HX-DZM-202119
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2022
• Source: Dongzhimen Hospital, Beijing
• Contact: Dandan Zhang, PhD, MD
• Phone: +8618810532113
• Email: zx1zy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1376
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• LongShengZhi capsule
LongShengZhi capsules, orally, 5 capsules each time, three times a day.
• LongShengZhi capsule placebo
LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The proportion of adverse events (AEs)	The proportion of AEs during the treatment.	90 days after randomization