Protocol summary
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Study aim
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Determining the effect of chamomile extract on postpartum depression
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Design
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Randomised, parallel group trial with blinded outcome assessment.
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Settings and conduct
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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 and at the end of treatment.
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Participants/Inclusion and exclusion criteria
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Women who have given birth will have mild to moderate depression
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Intervention groups
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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 and at the end of the bed of treatment.
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Main outcome variables
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The average score of depression; The severity of depression
General information
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Reason for update
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change in part of the protocol
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211207053313N1
Registration date:
2021-12-12, 1400/09/21
Registration timing:
prospective
Last update:
2023-10-10, 1402/07/18
Update count:
1
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Registration date
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2021-12-12, 1400/09/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-10, 1400/10/20
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Expected recruitment end date
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2022-01-20, 1400/10/30
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Actual recruitment start date
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2022-03-06, 1400/12/15
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Actual recruitment end date
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2022-05-05, 1401/02/15
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Trial completion date
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2022-09-06, 1401/06/15
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Scientific title
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The effect of Matricaria Chamonail on postpartum depression
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Public title
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The effect of Matricaria Chamonail on postpartum depression
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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:
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
144
Actual sample size reached:
128
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-11-23, 1400/09/02
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Ethics committee reference number
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IR.AJUMS.REC.1400.523
Health conditions studied
1
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Description of health condition studied
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Postpartum depression
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The average score of depression
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Timepoint
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Before the intervention nd 8 weeks after the start of treatment
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Method of measurement
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Beck Depression questionnaire
2
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Description
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The severity of depression
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Timepoint
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Before the intervention and 8 weeks after the start of treatment
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Method of measurement
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Beck depression questionnaire
Intervention groups
1
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Description
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Intervention group: People will be advised to take two capsules of 500 mg of chamomile extract daily. Patients will be contacted twice a week. 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 Darou company are prepared. Participants received 1,000 mg daily (twice daily) for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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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. t. 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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable