]>
IRCT20220309054235N1 IRCT 2022-03-27 Ahvaz University of Medical Sciences Effect of saffron in treatment of depression in diabetes patients The effect of adding saffron to fluoxetine in the treatment of mild to moderate depression in type 2 diabetes mellitus patients: A Randomized Double-Blinded Study 2022-04-21 anticipated 60 Complete https://irct.ir/trial/62502 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random numbers generation and using computer by excel software. Random numbers will be generated in Excel with RAND function [(=RAND()*(60)] and with this function 60 random numbers will be created in the range of 1 to 60 in a column. Each patient will be assigned a two-digit code from 01 to 60. From the beginning of the first row, move down the column of random numbers and check the first two digits of the random numbers. The first 30 people seen in our code range will be placed in the first group (intervention) and the second 30 people will place in the second group (control). A person from hospital staff, who will not responsible for patient selection, enrollment, or treatment allocation, performs the randomization. The patients will be included in one of the two treatment groups before starting treatment. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment, Blinding description: In this study, physicians, nurses, data collectors, those assessing the consequences, and the Safety and Data Monitoring Committee will be kept blind. In order to eliminate the bias caused by the knowledge of them, the results are based on the type of treatment received and its possible impact on the research result of the study in a double-blind manner. The appearance of the placebo will be similar to that of saffron capsule. Also patients and statistical analyzer will not know about patient grouping. 3 Mild to moderate depression. Intervention 1: Intervention group: Fluoxetine 10 mg, once a day (Abidi Pharmaceutical Company, Iran) will be prescribed for 4 weeks and then the patients will be received Deprofade saffron capsule 20 mg per day (Tolou Gostar Bokhara Company, Iran) along with fluoxetine 10 mg for 4 weeks. Intervention 2: Control group: Fluoxetine 10 mg (Abidi Pharmaceutical Company, Iran) will be prescribed for 4 weeks and then patients receive a similar capsule containing placebo (prepared in the Faculty of Pharmacy of Ahvaz Jundishapur University) along with fluoxetine for 4 weeks (The appearance of the placebo is similar to that of saffron cap). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Masumeh Ebrahimilagha
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 933 312 7369 Dr_masumelagha@yahoo.com Ahvaz University of Medical Sciences scientific Masumeh Ebrahimilagha
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 933 312 7369 Dr_masumelagha@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 18-60 years Diabetes mellitus type 2 Mild to moderate depression Fasting blood sugar less than 170 mg/dl Body mass index between 18.5 to 40 Consent to participate in the study 18 years 60 years Both Consumption of psychiatric drugs before the study Substance abuse Insulin consumption Uncontrolled diabetes (HbA1c above 8%) History of severe stress Pregnancy Lactation other psychiatric illnesses including anxiety disorders Previous history of depression Mental disability F32 Major depressive disorder, single episode Treatment - Drugs Treatment - Drugs Intervention group: Fluoxetine 10 mg, once a day (Abidi Pharmaceutical Company, Iran) will be prescribed for 4 weeks and then the patients will be received Deprofade saffron capsule 20 mg per day (Tolou Gostar Bokhara Company, Iran) along with fluoxetine 10 mg for 4 weeks. Control group: Fluoxetine 10 mg (Abidi Pharmaceutical Company, Iran) will be prescribed for 4 weeks and then patients receive a similar capsule containing placebo (prepared in the Faculty of Pharmacy of Ahvaz Jundishapur University) along with fluoxetine for 4 weeks (The appearance of the placebo is similar to that of saffron cap). The severity of depression. Timepoint: Before and after intervention (the end of 8 week of treatment). Method of measurement: Measurement of severity of depression based on the Hamilton Rating Scale for Depression (HRSD) score. Incidence of treatment-related complication. Timepoint: During the intervention every week until the end of 8 week of treatment. Method of measurement: Based on the evaluation of patients' symptoms at weekly visits and incidence of any side effects related to treatment such as dry mouth, sleep disorders, headaches, digestive problems, urinary problems, sexual function problems and etc. Ahvaz University of Medical Sciences Approved 2021-11-09 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)