se of probiotics in the treatment of schizophrenia
- Conditions
- Health Condition 1: F200- Paranoid schizophrenia
- Registration Number
- CTRI/2022/06/042960
- Lead Sponsor
- VIBRONICA A Division of Kepler heathcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Patients aged 18-45 years.
2.ICD -10 diagnosis of schizophrenia any type or schizoaffective disorder with disease duration of atleast 2 years.
3.Willing to participate in the study
4.Education of 9th std and above
5.Scores on the Positive and Negative Syndrome Scale (PANSS) indicative of at least moderately severe psychosis, total PANSS score >= 50.
6.Cognitive deficit below 15th percentile in any one cognitive domain of NIMHANS battery.
1.Patients who are uncooperative due to the severity of the illness.
2.Existence of serious medical/neurological disorder, known allergic to Probiotics.
3.Patients with diagnosis of mental retardation.
4.Primary diagnosis of substance abuse or dependence within the last 3 months.
participated in any investigational drug trial in the past 30 days;
5.Women who were currently pregnant, planning to get pregnant /breastfeeding.
Not consenting to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fasting serum insulin, insulin resistance, body mass index, fasting blood glucose, lipid profile and body weightTimepoint: baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method PANSS scores <br/ ><br>cognitive symptoms (executive function, attention and memory)Timepoint: baseline, 4 ,8 and 12 weeks.