]>
IRCT20160804029191N4 IRCT 2021-12-11 Mashhad University of Medical Sciences Effect of silymarin in the treatment of patients with depression Evaluation of the additive effect of silymarin in the treatment of patients with moderate depression 2022-01-21 anticipated 80 Complete https://irct.ir/trial/59983 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method (using https://www.Randomization.com-generated sequence) In this method, using website https://www.Randomization.com that generates the random number sequences, the random number sequences are determined for the required sample size (n=40 in each group). Following, after patients enter the study based on the inclusion criteria, according to the list of the random number sequences generated, individuals are assigned to one of the intervention and placebo groups, and this continues until the number of patients in each group is completed, Blinding description: Drugs will be packed and labelled. No information on the randomization schedule or the contents of drug packs will be available to patients, investigators, care providers and outcomes assessors and they will be blinded. The patients will be blinded in the sense that they do not know whether they were receiving the placebo or silymarin. They randomly assign to one of the two groups. Outcomes assessors shall be blinded as to what group the patient belongs to. One person in the project who does not belong to any of the groups of patients, investigators, care providers and outcomes assessors, will oversee on blinding method. 3 Depression. Intervention 1: Placebo Group in which, patients (n=40) will receive placebo tablets twice a day, for 8 weeks. Intervention 2: Silymarin Group in which, patients (n=40) will receive silymarin 140 mg, twice a day, for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Dr. Vahideh Ghorani is committed to presenting all the achievements of the project in accordance with the framework of Mashhad University of Medical Sciences.
public Maedeh Kamrani
Ibn-e-Sina hospital, Horr-e-Ameli St.
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2701 Kamranim@mums.ac.ir Mashhad University of Medical Sciences scientific Maedeh Kamrani
Ibn-e-Sina hospital, Horr-e-Ameli St.
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2701 Kamranim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with moderate depression Being 20-50 years old Patient consent to participate in the study Not having specific physical (e.g. cancer, Acquired immunodeficiency syndrome (AIDS), Multiple Sclerosis (MS)) or mental illness Not having allergic to silymarin Not being pregnant/breast feeding 20 years 50 years Both Lack of patient cooperation in silymarin consumption Having allergic reaction or intolerable side effect caused by silymarin F32.1 Major depressive disorder, single episode, moderate Treatment - Drugs Treatment - Drugs Placebo Group in which, patients (n=40) will receive placebo tablets twice a day, for 8 weeks. Silymarin Group in which, patients (n=40) will receive silymarin 140 mg, twice a day, for 8 weeks Beck Depression Inventory (BDI) questionnaire. Timepoint: Before treatment (day 0) and at the end of weeks 4 and 8 after starting treatment. Method of measurement: Completion of the questionnaire by patient or researcher. General Health Questionnaire (GHQ). Timepoint: Before treatment (day 0) and at the end of weeks 4 and 8 after starting treatment. Method of measurement: Completion of the questionnaire by patient or researcher. Mashhad University of Medical Sciences Approved 2021-08-10 Ethics committee of Mashhad University of Medical Sciences Ghoreshi department, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)