Effect of Schizoherb on atypical antipsychotics-induced weight gai
Phase 3
- Conditions
- Weight gain side effect in patients with schizophrenia receiving atypical antipsychotics.Schizophrenia
- Registration Number
- IRCT20210707051813N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Age range 18 to 65 years
No serious systemic disease (including liver or kidney failure, known heart disease, hypothyroidism, hypertension) based on history and physical examination and lab tests and approved by a psychiatrist
No changes in the type and dose of antipsychotic drug in at least the last 3 months
Exclusion Criteria
Dependence on substances (except cigarettes)
Women during pregnancy or lactation
Liver functional tests more than twice normal
History of allergies to any of the plants in the design
Consumers of aripiprazole
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight. Timepoint: Before the beginning of study (week zero) and the end of study (week eight). Method of measurement: Measuring body weight (in kilograms) and height (in meters) and calculating body mass index or BMI (in kg / m2), measuring waist circumference with a tape measure (in centimeters) and calculating WHR (waist- hip circumference ratio).
- Secondary Outcome Measures
Name Time Method Evaluation of the severity of positive and negative symptoms of schizophrenia. (According to the available articles, the herbs used in the design are expected to be effective in reducing negative symptoms. In most interventional studies in schizophrenic patients, the severity of symptoms is assessed during the study.). Timepoint: weeks 0, 4 , 8. Method of measurement: PANSS questionnaire.;Fasting blood suger. Timepoint: beginning and end of the study. Method of measurement: by blood sample (in mg/dl).;Lipid profile. Timepoint: beginning and end of the study. Method of measurement: by blood sample (in mg/dl).;Measuring blood pressure. Timepoint: beginning and end of the study. Method of measurement: Using a mercury barometer (in mmhg).;Check the quality of life. Timepoint: beginning and end of the study. Method of measurement: Using the World Health Organization quality of life questionnaire (WHOQol - Bref).