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IRCT20211223053499N1 IRCT 2022-01-21 Hamedan University of Medical Sciences The effect of clove in depression Phytochemical evaluation and clinical effect of Syzygium aromaticum in comparison with the control group on reducing depression in depressive patients: a triple-blind randomized clinical trial 2022-01-24 anticipated 70 Complete https://irct.ir/trial/60839 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the balanced block randomization (block size: 4). We prepare four sheets of paper. On the two sheets we write the ((I)) meaning "Intervention" and on the other two sheets we write the ((P)) meaning "Placebo". Mix the sheets together and place them in the table drawer. With the referral of each eligible patient, one of the sheets was randomly pulled out and based on this sheet, I or P was drawn to one of the two groups of intervention (receiving standard treatment with cloves) or control (receiving Standard treatment with placebo). It should be noted that the pulled out sheets will not be returned to the drawer until all four sheets have been pulled out. After randomly pulling out all four sheets, all the sheets are returned to the drawer and the above operation will be continued for the next four patients until the desired sample size (70 patients) is reached, Blinding description: Containers containing clove essential oil with dark cans with open lids containing cloves in the form of X and placebo containers with dark cans with open lids containing wheat in the form of Y will be recognized and will be provided to the physician. Only the researcher is aware of the contents of the capsules, the patient's examining physician and the patient himself/herself, will not be aware of any of the contents of the labeled capsules. Therefore, the study design will be triple-blind. 3 Condition 1: Major depressive disorder, single episode, moderate. Condition 2: Major depressive disorder, single episode, mild. Condition 3: Major depressive disorder, recurrent, mild. Condition 4: Major depressive disorder, recurrent, moderate. Condition 5: Major depressive disorder, single episode, severe without psychotic features. Condition 6: Major depressive disorder, recurrent severe without psychotic features. Condition 7: Bipolar disorder, current episode depressed, mild or moderate severity. Condition 8: Bipolar disorder, current episode depressed, severe, without psychotic features. Intervention 1: Intervention group: 2 months of standard treatment (sertraline) + inhalation of one puff per day of 5% clove essential oil (diluted in ethanol) applied to the collar of the shirt + placing the container containing the clove next to the pillow at a certain distance during the night. Merck ethanol. Essential oil prepared in the pharmacognosy laboratory of Hamadan University of Medical Sciences. Intervention 2: Control group: 2 months of standard treatment (sertraline) + inhalation of a puff per day placebo (ethanol) applied to the collar of the shirt + placing the container containing wheat next to the pillow at a certain distance during the night. Merck ethanol. 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 Not any more information.
public Sara Javan
Fahmideh
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0548 sarajavan2014@gmail.com Hamedan University of Medical Sciences scientific Dara Dastan
فهمیده
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0548 dara962@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Aged 18 to 65 years A patient with major depressive disorder or bipolar disorder in the depressive episode 18 years 65 years Both Existence of psychotic symptoms Cognition disorders Anxiety disorders Schizophrenia Antisocial personality disorder Mental retardation Dementia Pregnancy Lactation Explicit suicidal ideation History of allergy to herbal drugs Having a proven problem with the sense of smell F32.1 F32.0 F33.0 F33.1 F32.2 F33.2 F31.3 F31.4 Major depressive disorder, single episode, moderate Major depressive disorder, single episode, mild Major depressive disorder, recurrent, mild Major depressive disorder, recurrent, moderate Major depressive disorder, single episode, severe without psychotic features Major depressive disorder, recurrent severe without psychotic features Bipolar disorder, current episode depressed, mild or moderate severity Bipolar disorder, current episode depressed, severe, without psychotic features Treatment - Drugs Placebo Intervention group: 2 months of standard treatment (sertraline) + inhalation of one puff per day of 5% clove essential oil (diluted in ethanol) applied to the collar of the shirt + placing the container containing the clove next to the pillow at a certain distance during the night. Merck ethanol. Essential oil prepared in the pharmacognosy laboratory of Hamadan University of Medical Sciences. Control group: 2 months of standard treatment (sertraline) + inhalation of a puff per day placebo (ethanol) applied to the collar of the shirt + placing the container containing wheat next to the pillow at a certain distance during the night. Merck ethanol. Depression rate. Timepoint: Weeks 0, 4 and 8 after the start of the intervention. Method of measurement: Hamilton Depression Inventory 17 items and Clinical Global Impression Questionnaire. Hamedan University of Medical Sciences Approved 2021-12-12 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Martyr Fahmideh Street, Hamadan Hamadan Hamadan Iran (Islamic Republic of)