Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI
Primary Purpose
Ischemic Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sodium oligomannate
Placebo capsule
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Stroke focused on measuring Post-stroke cognitive impairment, gut microbiota, Sodium oligomannate
Eligibility Criteria
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.
Sites / Locations
- Nanfang Hospital,Southern Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Control group
Arm Description
Subjects randomized to the trial group will receive sodium oligomannate 450mg twice daily for 24 weeks.
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.
Outcomes
Primary Outcome Measures
Incidence of PSCI
Proportion of patients in both groups with a corrected MoCA score of < 22 at 24 weeks of medication
Secondary Outcome Measures
Incidence of adverse events
The proportion of patients who had any adverse effect during the study period
The difference of MoCA value from cardinality
The difference between the MoCA value at 24 weeks of medication and the MoCA value at enrollment
Differences in ADAS-cog values from cardinality
The difference between the ADAS-cog value at 24 weeks of medication and the ADAS-cog value at enrollment.
Full Information
NCT ID
NCT05545605
First Posted
September 15, 2022
Last Updated
March 22, 2023
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05545605
Brief Title
Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI
Official Title
Efficacy and Safety of Sodium Oligomannate in the Prevention of Post-stroke Cognitive Impairment in Patients With Ischemic Stroke:a Randomized, Double-blind, Exploratory Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Post-stroke cognitive impairment, gut microbiota, Sodium oligomannate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Subjects randomized to the trial group will receive sodium oligomannate 450mg twice daily for 24 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium oligomannate
Intervention Description
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
Intervention Name(s)
Placebo capsule
Intervention Description
the control group (receiving placebo capsule) for 24 weeks.
Primary Outcome Measure Information:
Title
Incidence of PSCI
Description
Proportion of patients in both groups with a corrected MoCA score of < 22 at 24 weeks of medication
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
The proportion of patients who had any adverse effect during the study period
Time Frame
6 months
Title
The difference of MoCA value from cardinality
Description
The difference between the MoCA value at 24 weeks of medication and the MoCA value at enrollment
Time Frame
6 months
Title
Differences in ADAS-cog values from cardinality
Description
The difference between the ADAS-cog value at 24 weeks of medication and the ADAS-cog value at enrollment.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Yin, M.D
Phone
13802964883
Email
jiajiayin@139.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yiting Deng, M.D
Phone
15625070887
Email
751771431@qq.com
Facility Information:
Facility Name
Nanfang Hospital,Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Yin, D.M
Phone
13802964883
Email
jiajiayin@139.com
First Name & Middle Initial & Last Name & Degree
Yiting Deng, D.M
Phone
15625070887
Email
751771431@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI
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