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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Subjects randomized to the trial group will receive sodium oligomannate 450mg twice daily for 24 weeks. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium oligomannate | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PSCI | Proportion of patients in both groups with a corrected MoCA score of < 22 at 24 weeks of medication | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | The proportion of patients who had any adverse effect during the study period | 6 months |
| The difference of MoCA value from cardinality | The difference between the MoCA value at 24 weeks of medication and the MoCA value at enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Yin, M.D | Contact | 13802964883 | jiajiayin@139.com | |
| Yiting Deng, M.D | Contact | 15625070887 | 751771431@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Baiyun | 510515 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
| Placebo capsule | Drug | the control group (receiving placebo capsule) for 24 weeks. |
|
| 6 months |
| 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. | 6 months |
| Nanfang Hospital,Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |