Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI

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

RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-12-31

Brief Summary

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Post-stroke cognitive impairment (PSCI) is a common complication of stroke, and seriously affect the quality of survival and the survival time in patients with stroke, PSCI is still lack of effective prevention and treatment measures, the study found that gut microbiota are closely associated with stroke and cognitive diseases, sodium oligomannate can improve cognitive function of mild-to-moderate alzheimer's disease (AD) , The Expert Consensus 2021 on the Management of Post-stroke cognitive impairment states that the role of sodium oligomannate in PSCI needs to be investigated in large sample clinical trials. This study intends to explore the efficacy and safety of sodium oligomannate in the prevention of PSCI in patients with acute ischemic stroke and cognitive impairment, so as to provide a potential intervention for the prevention of PSCI.

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Detailed Description

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This clinical study was a randomized (1:1), double-blind, single-center, parallel controlled clinical study. The study period was 6 months to evaluate the efficacy and safety of sodium oligomannate in the prevention of PSCI in patients with ischemic stroke. Patients with acute ischemic stroke were recruited. After signing informed consent, patients who met the inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive treatment in the trial group (receiving sodium oligomannate) or the control group (receiving placebo capsule). A total of 116 patients were enrolled.And safety assessment and survival follow-up were performed at 4 weeks, 12 weeks and 24 weeks, and efficacy assessment was performed at 12 weeks and 24 weeks.

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Statistical researchers from the partner Shanghai Green Valley Pharmaceutical Co., LTD., used statistical software packages to generate two sets of 58 random drug numbers, which were determined in the form of files after the codes were formed.Masking the participant and investigator.

Study Groups

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Intervention group

Subjects randomized to the trial group will receive sodium oligomannate 450mg twice daily for 24 weeks.

Group Type EXPERIMENTAL

Sodium oligomannate

Intervention Type DRUG

Patients with acute ischemic stroke were recruited, and after signing informed consent, those who met the inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive treatment in the trial group (receiving sodium oligomannate)

Control group

Subjects randomized to the control group will receive a 450mg placebo capsule twice daily for 24 weeks that has exactly the same appearance and smell as the Intervention group.

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DRUG

the control group (receiving placebo capsule) for 24 weeks.

Interventions

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Sodium oligomannate

Patients with acute ischemic stroke were recruited, and after signing informed consent, those who met the inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive treatment in the trial group (receiving sodium oligomannate)

Intervention Type DRUG

Placebo capsule

the control group (receiving placebo capsule) for 24 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1.The first occurrence of ischemic stroke, which met the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, was confirmed by CT or MR; 2. The onset of illness was less than 7 days after admission, aged 18-80 years; 3. Clear consciousness, able to cooperate with cognitive and other tests, NIHSS score ≤15; 4. Before onset, the patient's cognitive level was normal, daily life and social activities were normal; 5. Stay in the current place of residence for more than 3 years; 6. With cognitive assessment, MoCA \< 22 (years of education \< 12, +1) after correction, and signed the informed consent.

Exclusion Criteria

* 1.Unable to cooperate with neuropsychological examination due to various reasons (such as consciousness disorders, vision disorders, hearing disorders, etc.); 2. Combined with other diseases (such as intracranial mass, demyelinating disease, intracranial infection, neurodegenerative disease, epilepsy, severe heart, liver, kidney, blood system or other system diseases, etc.); 3. Used antibiotics 3 months before onset; 4. A history of alcohol abuse, drug use, or serious mental illness (including major depression (HAMD \> 10)) before onset of illness, 5. No stool was collected within 7 days of onset.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No