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IRCT20210707051813N1 IRCT 2021-08-21 Mashhad University of Medical Sciences "Effect of Schizoherb on atypical antipsychotics-induced weight gain" Evaluation the effect of Schizoherb on atypical antipsychotics-induced weight gain in patients with schizophrenia 2021-09-23 anticipated 64 Complete https://irct.ir/trial/57361 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using sealedenvelope.com and random blocking method, patients are placed in the intervention or control group. 16 blocks of 4 will be produced and the sequence produced by the design statistician will be placed in opaque sealed envelopes and numbered, respectively, Blinding description: The study is three-blinded (blinding the subjects, evaluators and analysts). Instead of the intervention and control group, A and B are used to blind the analyst. The outcome assessor is someone outside the research group. The intervention group is given Schizoherb herbal capsules in addition to previous medications and the control group is given placebo capsules in addition to previous medications. 3 Weight gain side effect in patients with schizophrenia receiving atypical antipsychotics. Intervention 1: Simultaneously with the continuous use of antipsychotic drugs, in the intervention group, Schizoherb capsules (including three herbs green tea, Persian borage and portulaca oleracea, formulated in the laboratory of Mashhad School of Traditional and Complementary Medicine, Iran), in the form of 700 mg capsules are prescribed twice a day for 8 weeks. Intervention 2: Control group: In the control group, placebo capsules containing Avisel, made in the laboratory of Mashhad School of Traditional and Complementary Medicine, are added to the patient's treatment regimen for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is I have not decided yet - its release schedule is not yet known
public Hamideh Naghibi
Azadi Square, east door of the university campus, Faculty of Iranian and Complementary Medicine, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8931 naghibih1@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammadreza Fayyazi bordbar
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo-Ali square
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2721 FayyaziMR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 F20 Schizophrenia Treatment - Drugs Treatment - Drugs Simultaneously with the continuous use of antipsychotic drugs, in the intervention group, Schizoherb capsules (including three herbs green tea, Persian borage and portulaca oleracea, formulated in the laboratory of Mashhad School of Traditional and Complementary Medicine, Iran), in the form of 700 mg capsules are prescribed twice a day for 8 weeks. Control group: In the control group, placebo capsules containing Avisel, made in the laboratory of Mashhad School of Traditional and Complementary Medicine, are added to the patient's treatment regimen for 8 weeks. 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). 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). 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. Mashhad University of Medical Sciences Approved 2021-06-19 Ethics Committee of Mashhad University of Medical Sciences Ghoreishi Building, Daneshgah Street mashhad Razavi Khorasan Iran (Islamic Republic of)