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IRCT20090117001556N149 IRCT 2023-04-04 Tehran University of Medical Sciences The effect of saffron on binge eating disorder Evaluating the effect of Crocus sativus L. (Saffron) on appetite and weight of subjects with binge eating disorder: A randomized, double-blind, placebo-controlled clinical trial 2023-05-22 anticipated 50 Complete https://irct.ir/trial/69361 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups), Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 The severity of binge eating disorder. Intervention 1: Control group: patients take placebo capsules twice a day for three months. Intervention 2: Intervention group: patients take saffron capsules with a dose of 15 mg twice a day for three months. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2023 to 2028 To whom: Academic researchers Conditions: Users should cite the resource of data Where to obtain: Prof. Shahin Akhondzadeh How to obtain: By E-mail Comments:
public Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Individuals with binge eating disorder confirmed by the SCID-V semi-structured questionnaire No specific diet Normal physical activity No drug or non-drug treatment 18 years 60 years Both Diabetes Cancer Drug addiction Thyroid dysfunction Drugs effective in appetite and weight Taking psychiatric drugs Stomach surgery or taking food supplements Diagnosis of other eating disorders F50.02 Anorexia nervosa, binge eating/purging type Placebo Treatment - Drugs Control group: patients take placebo capsules twice a day for three months. Intervention group: patients take saffron capsules with a dose of 15 mg twice a day for three months. The severity of binge eating disorder. Timepoint: Baseline, and weeks 4, 8, 12. Method of measurement: By SCID-V semi-structured questionnaire - DASS-21 questionnaire. Tehran University of Medical Sciences Approved 2023-01-02 Ethics Committee of School of Medicine, Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)