Determining the effect of Curcumax capsule on postpartum depression
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 124 patients, randomized permutation block method with block size 6 is used for randomization.
Settings and conduct
The research is carried out in Health Center No. 3 of West Ahvaz, which is first identified by screening patients and then randomly entered into intervention and control groups. Uniform envelopes are used in packages and mats containing drugs, which are numbered according to the table of random permutations, and the researcher and sample are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-15 years old, first or second pregnancy, literacy, term delivery, healthy baby delivery, low risk pregnancy and no chronic diseases having Exclusion criteria: a history of allergies to herbal medicines, drug addiction, severe depression
Intervention groups
People in the intervention group are given Curcumax capsules once a day after lunch and the control group is given a placebo (starch) capsule once a day after lunch for 8 weeks.
Main outcome variables
Postpartum Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210822052254N1
Registration date:2021-09-21, 1400/06/30
Registration timing:prospective
Last update:2021-09-21, 1400/06/30
Update count:0
Registration date
2021-09-21, 1400/06/30
Registrant information
Name
Fatemeh Nikpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 2414
Email address
nikpour.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Curcumax capsule (containing three plants: ginger, turmeric, black pepper) on postpartum depression: a double-blind clinical trial
Public title
The effect of curcumax on postpartum depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 35-18 years
First or second pregnancy
Score 11 to 23 on the Edinburgh Depression Inventory
Literacy for reading and writing
Term delivery
Healthy baby delivery
Low risk pregnancy
No chronic diseases
Exclusion criteria:
Having a history of allergies to herbal medicines
Drug addiction
major depression
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the intervention to individuals in each of the intervention and control groups (62 people in each group) randomly and by the method of random permutation blocks with a random block size of 6 (using the table related to random permutations) and the allocation ratio 1 : 1 is. The tool for generating random block sequences is blockrand software package in R software environment. Coding is done by a biostatistics specialist to set up a random list.
Blinding (investigator's opinion)
Double blinded
Blinding description
The required number of Curcumax and placebo capsules for consumption for 8 weeks and by an uninformed person other than those involved in the research, the content of the research will be pre-packaged in opaque bags and in the same form of packaging and coding (A: intervention; B: control). And in this sense it will be blind to researchers. Individuals are asked to pick up an envelope at random. The code of each envelope that the person picks up is recorded in the questionnaire and is continued in this way until the sampling of 124 people is completed. The code of each envelope is encoded by someone other than the researchers and will not be decrypted until the data is analyzed and will be blinded at this stage.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz - Golestan - Esfand St. - Ahvaz Jundishapur University of Medical Sciences - School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Approval date
2021-07-19, 1400/04/28
Ethics committee reference number
IR.AJUMS.REC.1400.336
Health conditions studied
1
Description of health condition studied
Postpartum Depression
ICD-10 code
F53
ICD-10 code description
Mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Postpartum Depression Score in the Edinburgh Questionnaire
Timepoint
Initiation of the study, 4 and 8 weeks after the start of the intervention
Method of measurement
Edinburgh Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 8 weeks, they receive Curcumax Health Aid capsules (300 mg of turmeric extract, 5 mg of ginger extract, 2.5 mg of black pepper extract) once a day.
Category
Treatment - Drugs
2
Description
For 8 weeks, they receive a placebo capsule containing 300 mg of starch once a day. The placebo capsule is made in the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 3 West of Ahvaz
Full name of responsible person
Dr. Faezeh Al-Bushoka
Street address
Khuzestan Province, Ahvaz, Hasheminejad Blvd., Kordoni St., Farahani St., Modares St., Treatment Center No. 3 West of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3339 2293
Email
nikpour.f@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz University City - Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences and Health Services - Ground Floor
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
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
Fatemeh Nikpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fars province-Mohr city-Varavi city-Imam Hossein street
City
Mohr
Province
Fars
Postal code
74414-37859
Phone
+98 71 5284 3345
Email
nikpoor28f@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Somayeh Ansari
Position
the coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Golestan Road, University City, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8395
Email
Ansarisomayeh88@gmil.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Nikpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fars province, Mohr city, Varavi city, Imam Hossein street
City
Mohr
Province
Fars
Postal code
74414-37859
Phone
+98 71 5284 3345
Email
nikpoor28f@gmail.com
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
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available