临床试验/CTRI/2025/09/095305

CTRI/2025/09/095305尚未招募2 期

Probiotics as an adjunctive therapy in cognitive symptoms of Schizophrenia and its correlation with serum biomarkers and metabolic profile : A double-blind randomized placebo controlled study

Central institute of Psychiatry ,Ranchi1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2025年10月4日最近更新: 2025年9月13日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 50
试验地点: 1
主要终点: Outcome: Change in cognitive function scores measured by Hindi Montreal Cognitive Assessment (MoCA) from baseline to 4 weeks between probiotic and placebo groups.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

the group 1 (25 patients) receive probiotics and the group 2 (25 patients) receive placebo for 4 weeks .then both groups will be evaluated on PANSS,MOCA, SERUM IL6,BDNF,hsCRP,FBS,BMI,Triglyceride at baseline.this will be repeated with the application of SAFTEE at 2 weeks and 3 weeks

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Participants satisfying the ICD 10-DCR [1993] criteria of schizophrenia
•60 years of both sexes.
•Illness duration of equal to or more than 2 years
•Patient giving written informed consent.
•Score between 18 to 25 on screening with Hindi Montreal Cognitive Assessment Test (Hindi MoCA).

排除标准

•Any other major co-morbid psychiatric diagnosis excluding anxiety disorder, dissociative disorder, adjustment disorders and substance dependence excluding nicotine& caffeine.
•Presence of any medical,surgical and psychiatric emergency.
•Any current systemic infection or inflammation or autoimmune disorders, currently using antibiotics, glucocorticoids and other probiotics, known hypersensitivity to probiotics.

结局指标

主要结局

Outcome: Change in cognitive function scores measured by Hindi Montreal Cognitive Assessment (MoCA) from baseline to 4 weeks between probiotic and placebo groups.

时间窗: Time Points: Baseline, 2 weeks, and 4 weeks.

次要结局

Change in serum IL-6, hs-CRP, and BDNF levels.

研究者

发起方

Central institute of Psychiatry ,Ranchi

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Shlok nagil

Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand

研究点 (1)

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