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

Comparison of changes in the overall score of the Hamilton Depression Inventory and the change in disease severity score and the overall progress score in the General Clinical Statement Questionnaire in patients with major depressive disorder or bipolar disorder in the depressive episode receiving standard treatment with clove and receiving standard treatment with placebo

A randomized clinical trial with a control group, parallel design, triple-blind, phase 3.

This clinical trial will be performed in Sina Hospital and Imam Khomeini Clinic in Hamadan. Spray containers containing clove essential oil with cans containing cloves will be identified as X and placebo spray containers with cans containing wheat will be identified as Y and will be provided to the physician. The blind mode will be triple-blind.

Inclusion criteria: A patient aged 16 to 85 years with major depressive disorder or bipolar disorder in the depressive episode; Exclusion criteria: the existence of psychotic symptoms; Anxiety disorders.

Intervention group: 2 months of sertraline + inhalation of a puff of 5% clove essential oil per day + placing the container containing the clove next to the pillow at a certain distance during the night control group: 2 months of sertraline + inhalation of a placebo puff per day + placing the container containing the wheat next to the pillow at a certain distance during the night

Score items of the Hamilton Depression Inventory score of Severity of illness, and Global improvement of Clinical Global Impression Questionnaire

Expanding the range of patients due to the lack of patients to conduct the study

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.

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.