Determining the effect of basil capsules on postpartum depression symptoms (primary outcome) and postpartum sleep quality (secondary outcome)
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial involving 78 participants. To use SAS software will be.
Settings and conduct
Individuals will be selected from Al-Zahra and Taleghani hospitals in Tabriz through face-to-face meetings. Basil and placebo capsules will be provided to the participants in opaque and similar cans. Placebo cans will be scented with basil essential oil. The person who is not involved in the sampling, will be asked to assess the outcome at the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a vaginal term birth or cesarean section, healthy baby, Literacy for reading and writing.
Exclusion criteria: Obtaining a score of 13 or higher in the Edinburgh Questionnaire, mental retardation, chronic diseases during pregnancy, the occurrence of a stressful event such as death or diagnosis of an incurable disease in first-degree family members, divorce, during the three months before the start of the study.
Intervention groups
Participants in the intervention group will receive 2 capsules of 500 mg containing dried green basil leaf powder daily for 8 weeks. Participants in the control group will receive 2 capsules of 500 mg containing starch daily, which are blinded They will receive the scented basil essence.
Main outcome variables
The average score of postpartum depression in the intervention and placebo groups after the completion of the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220926056046N2
Registration date:2023-02-21, 1401/12/02
Registration timing:prospective
Last update:2023-02-21, 1401/12/02
Update count:0
Registration date
2023-02-21, 1401/12/02
Registrant information
Name
Solmaz Ghanbari Homaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3524 5181
Email address
homayisolmaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-14, 1401/12/23
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ocimum Basilicum capsule on postpartum depression symptoms: A Randomized Controled Trial
Public title
The effect of Ocimum Basilicum on postpartum depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a vaginal term birth or cesarean section
Having a healthy baby
Being literate in reading and writing
Exclusion criteria:
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
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz university of medical science, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-01-23, 1401/11/03
Ethics committee reference number
IR.TBZMED.REC.1401.948
Health conditions studied
1
Description of health condition studied
postpartum depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
Postpartum sleep quality score
Timepoint
The end of the eighth week after the start of the intervention
Method of measurement
Postpartum sleep quality questionnaire
Intervention groups
1
Description
Intervention group: Participants in the intervention group will receive 2 capsules of 500 mg containing dried green basil leaf powder daily for eight weeks.
Category
Prevention
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Monireh Abdi
Street address
School of Nursing and Midwiferyو Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
m85438a@gmail.com
2
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Monireh Abdi
Street address
Railway Square
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 44 3344 4592
Email
m85438a@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Azadi St., Golgosht St., Tabriz University of Medical Sciences, Central Building No. 2, 3rd Floor, Research Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Monireh Abdi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shariati Street, Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 903 818 5438
Email
m85438a@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Ghanbari Homaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery school, Shariati street
City
Tariz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3524 5181
Email
homayisolmaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Ghanbari Homayi
Position
Assestant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3478 5229
Email
homayisolmaz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available