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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Incidence of PSCI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •The onset of illness was less than 7 days after admission, aged 18-80 years;
- •Clear consciousness, able to cooperate with cognitive and other tests, NIHSS score ≤15;
- •Before onset, the patient's cognitive level was normal, daily life and social activities were normal;
- •Stay in the current place of residence for more than 3 years;
- •With cognitive assessment, MoCA < 22 (years of education < 12, +1) after correction, and signed the informed consent.
排除标准
- •1.Unable to cooperate with neuropsychological examination due to various reasons (such as consciousness disorders, vision disorders, hearing disorders, etc.);
- •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.);
- •Used antibiotics 3 months before onset;
- •A history of alcohol abuse, drug use, or serious mental illness (including major depression (HAMD > 10)) before onset of illness,
- •No stool was collected within 7 days of onset.
研究组 & 干预措施
Intervention group
Subjects randomized to the trial group will receive sodium oligomannate 450mg twice daily for 24 weeks.
干预措施: Sodium oligomannate (Drug)
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.
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Incidence of PSCI
时间窗: 6 months
Proportion of patients in both groups with a corrected MoCA score of \< 22 at 24 weeks of medication
次要结局
- Differences in ADAS-cog values from cardinality(6 months)
- Incidence of adverse events(6 months)
- The difference of MoCA value from cardinality(6 months)