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IRCT20220426054668N1 IRCT 2022-06-21 Artesh University of Medical Sciences Evaluation of the effect of cloves in the treatment of depression Evaluation of the effect of clove-based Iranian traditional medicine (Eugenia Caryophyllata) On improving the score of Hamilton questionnaire in patients with depression 2021-06-30 anticipated 62 Complete https://irct.ir/trial/63251 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients are included in the study and are divided into two groups A and B by sequentially numbered method. Randomization is done by random number generator software in quadruple blocks, Blinding description: Participants and the physician are both blinded to the treatment received. After obtaining patient information, the researcher gives the patient a sealed envelope that contains code A (a product of traditional medicine based on cloves) or code B (placebo). Without opening the envelope, the patient presents it to the pharmacist's colleague, so that after the relevant code is determined, the drug A or B, which are covered by the manufacturer, will be given to the patient. The pharmacist colleague records the patient's name and code without identifying the medication, and this information will be kept until the end of the study. 2-3 Major depressive disorder. Intervention 1: Intervention group: Processed clove syrup; One gram of cloves with ten grams of pomegranate juice and one gram of honey are kept in an incubator at 40 ° C for one week. Then the desired syrup is prepared by adding sugar. The product will be stored in a sterile glass container and closed until dark, in the dark and in the refrigerator at 4 ° C. At a dose of 250 mg (3 cc) daily for 6 weeks. Intervention 2: Control group: placebo; Ten grams of pomegranate juice and one gram of honey are stored in an incubator at 40 degrees for one week. Then the desired syrup is prepared by adding sugar. The product will be stored in a sterile glass container and closed until dark, in the dark and in the refrigerator at 4 ° C. At a dose of 3 cc daily for 6 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Mohammadreza Ghasemzadeh
505 hospital, Oshan Blvd, Artesh Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1956944141 +98 21 2248 1806 m.rezaghasemzadeh@yahoo.com Artesh University of Medical Sciences scientific Mohammadreza Ghasemzadeh
The end of Avshan Boulevard, Artesh Boulevard, Aqdasiyeh
Tehran Iran (Islamic Republic of) 1956944141 +98 21 2248 1806 m.rezaghasemzadeh@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) A score of 19 or higher on the 17-item HAM-D Scoring Tool and a score of 2 or higher on the first HAM-D item no limit no limit Both Received any type of antidepressant in the past months Received electroshock during the last 2 months Having evidence in favor of psychosis or other mental illnesses Suicidal thoughts (score higher than 2 on HAM-D suicide item) Addiction or abuse of alcohol or other substances (excluding nicotine) Uncontrollable physical diseases such as thyroid, heart and liver diseases Patient dissatisfaction with participation in the study F32 Major depressive disorder, single episode Treatment - Drugs Placebo Intervention group: Processed clove syrup; One gram of cloves with ten grams of pomegranate juice and one gram of honey are kept in an incubator at 40 ° C for one week. Then the desired syrup is prepared by adding sugar. The product will be stored in a sterile glass container and closed until dark, in the dark and in the refrigerator at 4 ° C. At a dose of 250 mg (3 cc) daily for 6 weeks. Control group: placebo; Ten grams of pomegranate juice and one gram of honey are stored in an incubator at 40 degrees for one week. Then the desired syrup is prepared by adding sugar. The product will be stored in a sterile glass container and closed until dark, in the dark and in the refrigerator at 4 ° C. At a dose of 3 cc daily for 6 weeks. Depression score on the Hamilton questionnaire. Timepoint: Before the study, two, four and six weeks after starting treatment. Method of measurement: Hamilton Depression Inventory. Artesh University of Medical Sciences Approved 2021-07-03 Research Ethics Committees of AJA University of Medical Sciences AJA University of Medical Sciences, Shaheed Etemadzadeh St, West Fatemi Ave Tehran Tehran Iran (Islamic Republic of)