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IRCT20211202053250N2 IRCT 2022-07-24 Mashhad University of Medical Sciences The effect of crocin on weight gain in patients taking clozapine The effect of crocin on weight gain in patients taking clozapine 2022-06-20 anticipated 74 Complete https://irct.ir/trial/62712 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization will be done using the random block method. By using www.randomizer.org, randomization will be done using random blocks. In the optimization part, the list of random numbers will be generated as 37 blocks of 2. Based on that, people will be randomly assigned to one of the intervention and control groups using a sealed envelope, Blinding description: In this study, blinding will be done in relation to the participants in the research, researcher and data evaluator. The form of drugs and placebos is exactly the same, so the patient will not know the type of intervention. Also, the treating physician will not know the type of intervention. Therefore, the study will be conducted blindly. To evaluate the data, groups will be assigned a number instead of a name, so that the course can be evaluated. 3 Weight gain. Intervention 1: Intervention group: Taking 15 mg crocin tablets twice a day for 8 weeks. Intervention 2: Control group: Placebo tablets are prescribed twice a day for 8 weeks with appearance and protocol. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Mahboubeh Eslamzadeh
Ibn Sina Psychiatric Hospital, Hore Ameli Boulvared. Ferdowsi Square Mashhad
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3700 2202 EslamZadehMH@mums.ac.ir Mashhad University of Medical Sciences scientific Mahboubeh Eslamzadeh
Ibn Sina Psychiatric Hospital, Hore Ameli Boulvard. Ferdowsi Square Mashhad
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3700 2202 EslamZadehMH@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients taking clozapine for at least one month before the start of the study with a BMI greater than 25 or weight gain greater than 10% Age range 20 to 60 years Patient and guardian consent to participate in the study No entry of schizoaffective and bipolar patients No history of allergies to crocin No pregnancy and lactation Do not admit patients who are taking drugs that affect weight at the same time Do not admit patients who are addicted to drugs, stimulants and alcohol Lack of untreated medical condition affecting weight such as hypothyroidism 20 years 60 years Both No patient entering below the age range of 20 years and above 60 years No entry of schizoaffective and bipolar patients Absence of pregnancy and lactation Do not admit patients who are taking drugs that affect weight at the same time Do not admit patients who are addicted to drugs, stimulants and alcohol Lack of untreated medical condition affecting weight such as hypothyroidism Patient dissatisfaction to participate in the study E66.9 Simple obesity NOS Treatment - Drugs Treatment - Drugs Intervention group: Taking 15 mg crocin tablets twice a day for 8 weeks Control group: Placebo tablets are prescribed twice a day for 8 weeks with appearance and protocol Weight. Timepoint: It is measured in patients at time zero and at the end of weeks 4 and 8. Method of measurement: Balance. Waist size. Timepoint: It is measured in patients at time zero and at the end of weeks 4 and 8. Method of measurement: centimeter. Positive and negative symptoms of schizophrenia. Timepoint: It is measured in patients at time zero and at the end of weeks 4 and 8. Method of measurement: PANSS Test. Body Mass Index. Timepoint: It is measured in patients at time zero and at the end of weeks 4 and 8. Method of measurement: Height to weight ratio. Mashhad University of Medical Sciences Approved 2022-05-15 Ethics Committee of Mashhad University of Medical Sciences Ibn Sina Psychiatric Hospital, Hore ameli Blvd, Ferdowsi Squaree Mashhad Razavi Khorasan Iran (Islamic Republic of)