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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Nanfang Hospital,Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Contact Information
Primary
Jia Yin, M.D
jiajiayin@139.com
13802964883
Backup
Yiting Deng, M.D
751771431@qq.com
15625070887
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 116
Treatments
Experimental: Intervention group
Subjects randomized to the trial group will receive sodium oligomannate 450mg twice daily for 24 weeks.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov