Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT05545605
- Run by
- Nanfang Hospital, Southern Medical University
- People needed
- 116
- Starts
- 2023-04-01
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-06-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Nanfang Hospital, Southern Medical University — Guangzhou, Baiyun, China (enrolling)
- Nanfang Hospital,Southern Medical University — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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