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IRCT20190309042979N1 IRCT 2020-05-04 Mazandaran University of Medical Sciences The effect of Eugenia Caryophillat,s product on depression the therapeutic effect of Eugenia Caryophillat,s product in patients with depression 2019-04-22 anticipated 60 Complete https://irct.ir/trial/40512 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation to intervention and control groups Stratified Block Randomization Random number table Patients with Stritified Block Randomization will be divided into two groups of 30 interventions and placebo. In this method, the group of mild to moderate depressed patients is classified as stritified. By randomly selecting the block, the number of patients is determined and the type of intervention is determined using closed envelopes, Blinding description: Drug of Intervention and placebo ,are coded in the envelope, patient and researcher and physician none of them don t khnow about them.drug and placebo are the same in colour and size and smell. 3 Condition 1: Major depressive disorder, single episode, moderate. Condition 2: Major depressive disorder, single episode, mild. Intervention 1: Intervention Group: Eugenia Caryophillat,s product + S Citalopram - In this group, routine S-Sitalopram 20mg treatment daily one tablet plus clove product (Clove capsule) receive one capsule BD. Intervention 2: Control group:placebo+s citalopram - In this group, routine treatment with 20 mg of s citalopram routine plus one pill daily plus placebo (placebo capsule) receive one capsule BD. 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 further information
public Assie Jokar
Khazar street
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4000 publicrel@mazums.ac.ir Mazandaran University of Medical Sciences scientific Assie Jokar
Khazar street
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4000 publicrel@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) 1-Declaration of written consent of the candidate for participation 18-65 years old Detection of major depressive disorder based on DSM-5 and treated for more than 6 weeks Score 14 to 28 in the depression test 21 BDI-II questions 18 years 65 years Both symptoms of high mood suicide incidence The incidence of unknown side effect patient request pregnancy and lactation F32.1 F32.0 Major depressive disorder, single episode, moderate Major depressive disorder, single episode, mild Treatment - Drugs Treatment - Drugs Intervention Group: Eugenia Caryophillat,s product + S Citalopram - In this group, routine S-Sitalopram 20mg treatment daily one tablet plus clove product (Clove capsule) receive one capsule BD Control group:placebo+s citalopram - In this group, routine treatment with 20 mg of s citalopram routine plus one pill daily plus placebo (placebo capsule) receive one capsule BD Depression Score. Timepoint: Before the start of the intervention (week 0) and 14, 28 and 42 days after the start of the intervention. Method of measurement: Beck questionnaire. Mazandaran University of Medical Sciences Approved 2019-03-09 Ethics committee of Mazandaran University of Medical Sciences Khazar street Sari Mazandaran Iran (Islamic Republic of)