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IRCT20210525051404N1 IRCT 2021-08-10 Kerman University of Medical Sciences Therapeutic effect of saffron extract in patients with chronic schizophrenia Therapeutic effect of saffron extract on negative, positive and general symptoms of schizophrenia in comparison with placebo in patients with chronic schizophrenia 2021-08-23 anticipated 40 Complete https://irct.ir/trial/56908 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, sampling is available first and then eligible patients will be assigned to two groups by simple random sampling. For this purpose, first a random sequence will be created from the table of random numbers. Then the extracted even numbers will be assigned to the intervention group and the odd numbers will be assigned to the control group. This process will continue to reach the sample size, Blinding description: Blinding is two-way blind so that the participants and the research physician will not be aware of the distribution of saffron and placebo extract capsules, which are similar in color, size, shape and smell to the main drug. To hide the drugs and placebo, they will be placed in a sealed matte envelope numbered in a row. Envelopes will be prepared by a non-research person. 3 schizophernia. Intervention 1: Intervention group: Treated with 15 mg capsule of saffron extract twice a day with routine treatments. Intervention 2: Control group: Placebo is prepared in the form of a capsule that is similar to the saffron capsule in terms of shape, weight and color, and two tablets are prescribed daily. In addition, routine treatments are performed. Yes - There is a plan to make this available What will be shared: At the end of the study, some information including the effect of saffron medicine in the treatment of schizophrenia symptoms, after identifying individuals, will be shared with health enthusiasts. When: 2 months after data analysis To whom: Health researchers Conditions: In order to use the results and during the written request Where to obtain: Mahdi Haji Rezaei- Email How to obtain: The purpose of accessing data - requesting e-mail Comments:
public Mahdi Haji Rezaei
Shahid Beheshti Hospital, Jomhuri Blvd, Kerman, Iran
kerman Iran (Islamic Republic of) 7618833639 +98 34 3211 0409 mahdi_hajirezaei@yahoo.com Kerman University of Medical Sciences scientific Nabi Banna Zadeh Mahani
Shahid Beheshti Hospital, Jomhuri Blvd, Kerman, Iran
Kerman Iran (Islamic Republic of) 7618833639 +98 34 3211 0409 n_banazadeh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Schizophrenia according to the DSM-V-TR criteria stable symptoms Age between 18 and 65 years 18 years 65 years Both General medical problems (including coronary artery disease, metabolic syndrome, and neurological diseases) Drug abuse Taking antiplatelet drugs Taking herbal medicines Sensitivity to saffron F20 Schizophrenia Treatment - Drugs Placebo Intervention group: Treated with 15 mg capsule of saffron extract twice a day with routine treatments Control group: Placebo is prepared in the form of a capsule that is similar to the saffron capsule in terms of shape, weight and color, and two tablets are prescribed daily. In addition, routine treatments are performed. Negative symptoms of schizophernia. Timepoint: Beginning of research and end of research (fourth week). Method of measurement: Positive and Negative Syndrome Scale. Positive symptoms of schizophrenia. Timepoint: Beginning of research and end of research (fourth week). Method of measurement: Positive and Negative Syndrome Scale. General symptoms of schizophrenia. Timepoint: Beginning of research and end of research (fourth week). Method of measurement: Positive and Negative Syndrome Scale. Symptoms of anxiety. Timepoint: Beginning of research and end of research (fourth week). Method of measurement: Hamilton Anxiety Scale. Symptoms of depression. Timepoint: Beginning of research and end of research (fourth week). Method of measurement: Hamilton Depression Scale. Kerman University of Medical Sciences Approved 2021-05-23 Ethics committee of Kerman university of medical science Shahid beheshti Hospital, Jomhori Blv Kerman Kerman Iran (Islamic Republic of)