Actively Recruiting
Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-06-13
116
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First occurrence of ischemic stroke confirmed by CT or MRI, meeting Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018
- Stroke onset less than 7 days before admission
- Age between 18 and 80 years
- Clear consciousness and able to cooperate with cognitive and other tests
- NIHSS score of 15 or less
- Normal cognitive level and daily living activities before stroke
- Resided in current location for more than 3 years
- Cognitive assessment showing MoCA score less than 22 (adjusted for education level)
- Signed informed consent
You will not qualify if you...
- Unable to cooperate with neuropsychological tests due to consciousness, vision, or hearing disorders
- Presence of other diseases such as intracranial mass, demyelinating disease, intracranial infection, neurodegenerative disease, epilepsy, or severe heart, liver, kidney, blood, or other system diseases
- Use of antibiotics within 3 months before stroke onset
- History of alcohol abuse, drug use, or serious mental illness including major depression (HAMD > 10)
- No stool sample collected within 7 days of stroke onset
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Nanfang Hospital, Southern Medical University
Guangzhou, Baiyun, China, 510515
Actively Recruiting
2
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
Research Team
J
Jia Yin, M.D
CONTACT
Y
Yiting Deng, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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