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Evaluation of the Effect of BioZen D as Adjunctive therapy in improving Positive, Negative, Cognitive symptoms and Risk factors for Metabolic syndrome and Inflammatory markers in Schizophrenia patients

Evaluation of the Effect of BioZen D as Adjunctive therapy in improving Positive, Negative, Cognitive symptoms and Risk factors for Metabolic syndrome and Inflammatory markers in Schizophrenia patients: A Randomized, Double-blind, Placebo-Controlled Clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211118053100N1
Enrollment
70
Registered
2021-12-01
Start date
2021-12-22
Completion date
Unknown
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Positive and Negative symptoms, cognitive symptoms, Inflammatory Factors, Metabolic syndrome Risk Factors, BioZen D. Schizophrenia

Interventions

Intervention 1: Intervention group: BioZen D is a combination of natural probiotic product and 400 units of vitamin D? In the form of oral capsules in a package of cans containing 90 capsules, with or

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Having Schizophrenia based on DSM-V criteria and by Clinical Psychiatrist Interview Male orFemale Patients in the Age range of 18 to 65 years Having at least a Fifth grade Elementary Education Patients with schizophrenia who are taking Risperidone up to 6 mg per day and take Biperiden in case of Extrapyramidal Complications and 1 mg of Lorazepam in case of Insomnia.

Exclusion criteria

Exclusion criteria: Having a history of Brain Injury or Trauma based on Information in the Patient's file Having Mental Retardation based on the Information in the patient's file History of Opioid or Stimulant Substance use in the last Three months Taking Antidepressant or Stimulant Drugs Having an Allergy history to Probiotics or vitaminD drugs Receiving Antibiotics in 14 days before the Start of the study Pregnancy or Lactation Parkinson's disease based on Clinical Examination or Patient's record

Design outcomes

Primary

MeasureTime frame
Positive symptoms. Timepoint: The beginning of the study then every two weeks until the end of the study. Method of measurement: Positive and Negative Syndrome Scale.;Negative symptoms. Timepoint: The beginning of the study then every two weeks until the end of the study. Method of measurement: Positive and Negative Syndrome Scale.;Cognitive symptoms. Timepoint: The beginning of the study then every two weeks until the end of the study. Method of measurement: Montreal Cognitive Assessment.;Inflammatory factor, c-reactive protein test. Timepoint: Before and after the study. Method of measurement: Blood test.;Inflammatory factor, Erythrocyte sedimentation rate(ESR). Timepoint: Before and after the study. Method of measurement: Blood test.;Metabolic Syndrome Risk Factor, Fasting Blood Sugar. Timepoint: Before and after the study. Method of measurement: Blood Test.;Metabolic Syndrome Risk Factor, Fasting Lipid Profile. Timepoint: Before and after the study. Method of measurement: Blood test.

Secondary

MeasureTime frame
Difficulty in bowel movement. Timepoint: The beginning of the study then every two weeks until the end of the study. Method of measurement: Ask the patient on a 4-point scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAida Mohammadi

University of social welfare and rehabilitation sciences

aida_m91@yahoo.com+98 21 7787 4935

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026