Determining the effect of chamomile extract on postpartum depression
Design
Randomised, parallel group trial with blinded outcome assessment.
Settings and conduct
Women referring to health centers No.1 , NO.4, Modares and Farhangian of Dezful city who have the conditions to enter the study and have mild to moderate depression, enter the study. Individuals will be divided into two groups of 72 through random allocation. Each participant receives two capsules daily (placebo or chamomile extract 500mg) for 8 weeks. The trial is two-blind and the participant and the researcher do not know the type of treatment for each person. Beck Depression questionnaire will be completed at the beginning of treatment in the fourth week and at the end of treatment.
Participants/Inclusion and exclusion criteria
Women who have given birth will have mild to moderate depression
Intervention groups
Participants in each group received 1000 mg (twice a day) for 8 weeks of medication (placebo or extract). Beck depression questionnaire completed at the bigening, 4 weeks later and at the end of the bed of treatment.
Main outcome variables
The average score of depression; The severity of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211207053313N1
Registration date:2021-12-12, 1400/09/21
Registration timing:prospective
Last update:2021-12-12, 1400/09/21
Update count:1
Registration date
2021-12-12, 1400/09/21
Registrant information
Name
Maryam Eradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4223 1706
Email address
eradi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Matricaria Chamonail on postpartum depression
Public title
The effect of Matricaria Chamonail on postpartum depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a cell phone Women with mild to moderate depression who are in the second week after delivery until 6 months later.
Term, single and alive baby delivery
Being literate
Age 18 to 45 years
Women with mild to moderate depression who are in the second week after delivery until 6 months later.
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be divided into two groups of 72 people in the chamomile extract group and the placebo group by random block allocation method and using 6 blocks. In order to prevent the occurrence of selection bias, the Allocation Concealment method will be used by placing the sample code in closed and two-layer envelopes and keeping these envelopes with the secretary of health centers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done in the form of double-sided blinds; In order to reduce the possibility of information bias, the capsules will be coded by the pharmaceutical company. Patients and individuals who provide drugs or evaluate the results of the treatment will be unaware of the type of treatment assigned to each person.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
No. 491, Imamat St., Jomhuri Eslami Blvd., Dezful Town
City
Dezful
Province
Khouzestan
Postal code
6461158753
Approval date
2021-11-23, 1400/09/02
Ethics committee reference number
IR.AJUMS.REC.1400.523
Health conditions studied
1
Description of health condition studied
Postpartum depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The average score of depression
Timepoint
Before the intervention, 4 and 8 weeks after the start of treatment
Method of measurement
Beck Depression questionnaire
2
Description
The severity of depression
Timepoint
Before the intervention, 4 and 8 weeks after the start of treatment
Method of measurement
Beck depression questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People will be advised to take two capsules of 500 mg of chamomile extract daily. Patients will be contacted twice a week. The time to follow up and re-complete the questionnaire will be 4 weeks after the start of treatment and at the first visit, capsules will be given to them to continue treatment until week 8. At the end, Beck questionnaire will be completed by them. 500mg chamomile capsules standardized with 1.2% flavonoid of Gol Daroo company are prepared. Participants received 1,000 mg daily (twice daily) for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo capsules filled with saccharin powder are provided by Gol Daroo Company. The capsules are similar in shape, size and packaging to the capsules containing chamomile extract. The capsules will be named by the pharmaceutical company. Participants will receive placebo twice a day for 8 weeks. Patients will be contacted twice a week. The time to follow up and re-complete the questionnaire will be 4 weeks after the start of treatment. at the first visit, capsules will be given to them to continue treatment until week 8. At the end, Beck questionnaire will be completed by them.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center No.4
Full name of responsible person
Maryam Eradi
Street address
No. 491, Imamat St., Jomhuri Eslami Blvd.
City
دزفول
Province
Khouzestan
Postal code
6461158753
Phone
+98 61 4222 2589
Email
Eradi.mr@gmail.com
2
Recruitment center
Name of recruitment center
Health center No.1
Full name of responsible person
Maryam Eradi
Street address
Enghelab st.
City
دزفول
Province
Khouzestan
Postal code
6461100000
Phone
+98 61 4222 0013
Email
Eradi.mr@gmail.com
3
Recruitment center
Name of recruitment center
Farhangian health center
Full name of responsible person
Maryam Eradi
Street address
No. 491, Imamat St., Jomhuri Eslami Blvd
City
Dezful
Province
Khouzestan
Postal code
6461158753
Phone
+98 61 4222 2589
Email
Eradi.mr@gmail.com
4
Recruitment center
Name of recruitment center
Modares No.2 health center
Full name of responsible person
Maryam Eradi
Street address
No. 491, Imamat St., Jomhuri Eslami Blvd
City
Dezful
Province
Khouzestan
Postal code
6461158753
Phone
+98 61 4223 1706
Email
Eradi.mr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadimoghadam
Street address
Vice Chancery for Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Health Services, University Campus, Ahvaz
City
دزفول
Province
Khouzestan
Postal code
1111111112
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Eradi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Esfand St., Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6461158753
Phone
+98 61 4223 1706
Fax
Email
eradi.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Eradi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Esfand St., Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6461158753
Phone
+98 61 4223 1706
Fax
Email
eradi.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Eradi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Esfand St., Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6461158753
Phone
+98 61 4223 1706
Fax
Email
eradi.m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available