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IRCT20220926056046N2 IRCT 2023-02-21 Tabriz University of Medical Sciences The effect of Ocimum Basilicum on postpartum depression The effect of Ocimum Basilicum capsule on postpartum depression symptoms: A Randomized Controled Trial 2023-03-14 anticipated 78 Complete https://irct.ir/trial/68333 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were randomly assigned to one of the intervention (basil) and control (placebo) groups using SAS software and by the block method (blocks of six: for example, ABABAB) with a ratio of 1:1 (equal number of participants in intervention and control groups) will be allocated. In order to hide the allocation (Allocation Concealment), the allocation sequence will be done by a person not involved in the study. Basil and placebo capsules will be placed inside sealed opaque bottles that are numbered consecutively, Blinding description: Participants, researcher, data collector and outcome assessor will be blinded. Basil and placebo capsules are in the same shape and size in both groups and and will be placed in similar containers. The person who is not involved in the sampling, will be asked to assess the outcome at the end of the intervention. 3 postpartum depression. Intervention 1: Intervention group: Participants in the intervention group will receive 2 capsules of 500 mg containing dried green basil leaf powder daily for eight weeks. Intervention 2: Control group: The participants in the control group will receive 2 capsules of 500 mg daily containing starch flavored with basil essential oil. There will be no essential oil inside the capsules. For the purpose of blinding only, the pharmacist will scent the vials containing the placebo with basil essential oil. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant data is confidential.
public Monireh Abdi
Shariati Street, Faculty of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5138947977 +98 903 818 5438 m85438a@gmail.com Tabriz University of Medical Sciences scientific Solmaz Ghanbari Homaie
Nursing and Midwifery school, Shariati street
Tariz Iran (Islamic Republic of) 9876598765 +98 41 3524 5181 homayisolmaz@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having a vaginal term birth or cesarean section Having a healthy baby Being literate in reading and writing 15 years 49 years Female Obtaining a score of 13 and above in the Edinburgh Questionnaire Mental retardation Chronic diseases aggravated during pregnancy Occurrence of a stressful event such as death or diagnosis of an incurable disease in first-degree family members, divorce, within three months. Before starting the study F06.31 Mood disorder due to known physiological condition with depressive features Prevention Placebo Intervention group: Participants in the intervention group will receive 2 capsules of 500 mg containing dried green basil leaf powder daily for eight weeks. Control group: The participants in the control group will receive 2 capsules of 500 mg daily containing starch flavored with basil essential oil. There will be no essential oil inside the capsules. For the purpose of blinding only, the pharmacist will scent the vials containing the placebo with basil essential oil. Postpartum depression score. Timepoint: Before the start of the intervention and the end of the eighth week after the start of the intervention. Method of measurement: Edinburgh depression questionnaire. Postpartum sleep quality score. Timepoint: The end of the eighth week after the start of the intervention. Method of measurement: Postpartum sleep quality questionnaire. Tabriz University of Medical Sciences Approved 2023-01-23 Ethics Committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz university of medical science, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)