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IRCT20200418047116N4 IRCT 2023-10-09 Gonabad University of Medical Sciences The effect of Ziziphus jujube in the treatment of anxiety and depression Comparison of effect between Ziziphus jujube fruit and benzodiazepines in patients with depression and anxiety disorders treated with selective serotonin reuptake inhibitors 2023-11-22 anticipated 50 Complete https://irct.ir/trial/72857 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, when obtaining written consent, the possibility of complications for the patients (whether they are in the test group or the control group) is explained, and the patients are requested to report to the project manager or the doctor in case of any complications. Notify your specialist. In case of complications, the patient can be excluded from the study. Then, depending on the type of complication and with the opinion of their specialist doctor, their symptoms are treated. The patients have a close relationship with their doctor and the project manager throughout the study period, Randomization description: In the current study, patients suffering from anxiety and depression referring to the psychiatric clinic of Allameh Bahloul Gonabadi Hospital are selected using available sampling method.In order to assign the patients to two intervention and control groups, he used the method of quadruple permutation blocks in such a way that first six possible states of the blocks.Then people are assigned to the control group (A) and the intervention group (B) based on the block corresponding to the selected number. It will continue until the end of the sample volume, Blinding description: In this study, blinding is done only for the analyst in such a way that two treatment groups with two codes A and B will be determined in the software, and the analyst will not know the nature of the treatment codes. 3 Condition 1: anxiety. Condition 2: depression. Intervention 1: Intervention group: Intervention group: Jujube powder purchased from Shayna, a 15 gram sachet once a day, will be added to the main treatment (SSRI) for one month. Intervention 2: Control group: treated with a routine drug regimen including SSRI and BZD for one month. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: The researchers in university and other scientific institutes. Conditions: Help in managing of patients. Where to obtain: Data can be accessible through sending an email to the corresponding author. Negar Shafaei-Bajestani negar.shafaei89@gmail.com How to obtain: after sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Negar Shafaei Bajestani
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
Gonabad Iran (Islamic Republic of) 9691797852 +98 51 5723 6833 negar.shafaei89@gmail.com Gonabad University of Medical Sciences scientific Negar Shafaei Bajestani
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
Gonabad Iran (Islamic Republic of) 9691797852 +98 51 5723 6833 negar.shafaei89@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Referees to the specialized psychiatric clinic of Bohlool Hospital in Gonabad city who have been diagnosed with anxiety and depression disorders based on DSM-V criteria. Candidate patients for treatment with SSRI and benzodiazepines, Having written informed consent to participate in the study Age 18 to 65 years 18 years 65 years Both History of sensitivity to jujube fruit consumption (based on the individual's own report) History of addiction Pregnancy or intention to become pregnant History of other psychiatric disorders Breastfeeding Taking jujube or other herbal medicines during the last 4 weeks before the start of the study Contraindications for benzodiazepine or SSRI administration Mental retardation Taking drugs that interfere with study drugs F41.9 F32.9 Anxiety disorder, unspecified Major depressive disorder, single episode, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Jujube powder purchased from Shayna, a 15 gram sachet once a day, will be added to the main treatment (SSRI) for one month. Control group: treated with a routine drug regimen including SSRI and BZD for one month. Anxiety scores in the Beck questionnaire. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Beck anxiety questionnaire. Severity of Illness. Timepoint: One month and three months after the intervention. Method of measurement: Global Clinical Perception Questionnaire - Severity of Illness. Drowsiness check. Timepoint: One month and three months after the intervention. Method of measurement: Complications survey questionnaire. Gonabad University of Medical Sciences Approved 2023-01-25 Ethic committee of Gonabad University of Medical Science Gonabad - Asian Roadside - Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)