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Ethics committees
#1
2018-02-12, 1396/11/23
2019-07-27, 1398/05/05
20182019-0207-1227 00:00:00
IR.GMU.REC.1396.178
IR.GMU.REC.1398.076
IR.GMU.REC.1396.178IR.GMU.REC.1398.076
Protocol summary
Study aim
Determine the Effect of Scrophularia Striata on Breast Fissure of Lactating Women
Design
Clinical trial with two intervention group(Scrophularia Striata plant and Lanolin),Double blind,randomized, random sampling, randomly assigned to two groups of Scrophularia Striata and lanolin using NCSS software,the sample size is 80 people, this is a phase 3 clinical trial.
Settings and conduct
The location of this intervention is Ommolbanin and Imam Reza Hospital city of Mashhad. In this study, each intervention group used Scrophularia striata cream on nipple and Areola after feeding Three times a day for 7 days. Mothers in control group apply Lanolin on nipple and areola after each feeding for 7 days .
Participants/Inclusion and exclusion criteria
Inclusion Criteria: single-child delivery; have a term and healthy baby; exclusive breastfeeding; birth weight of more than 2500 grams and less than 4,000 grams.
Withdraw criteria:History of identified mental illnesses in mother, History of allergy to Scrophularia Striata and Lanolin.
Intervention groups
The intervention groups consisted of two groups of 40 each, the first group was Scrophularia striata and the second group is the control and received the Lanolin.
Main outcome variables
Reduction of nipple pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190315043059N1
Registration date:2019-03-31, 1398/01/11
Registration timing:prospective
Last update:2019-08-04, 1398/05/13
Update count:1
Registration date
2019-03-31, 1398/01/11
Registrant information
Name
Hamidreza Ebrahimisenu
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
ebrahimi.h.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Scrophularia Striata Plant on Breast Fissure of Lactating women
Public title
The Effect of Scrophularia Striata on Breast Fissure of Lactating women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single-child delivery
A term and healthy infant and exclusive breast milk nutrition
Birth weight of infant between 2500 to 4000 grams
Exclusion criteria:
Abnormality of mouth, palate, jaw or face in infant
Mother's disease to known underlying diseases (diabetes or any type of internal-surgical disease)
History of nipple abnormalities (flat or inverted nipples or any nipple malformation which is followed by burning or any history of nipple and areola operation in childhood)
History of identified mental illnesses in mother
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using the number cruncher statistical system (NCSS) software, the samples will randomly assign to one of the two groups of Scrophularia striata and lanolin.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients became blind because of the appearance and color of the ointment. Due to lack of knowledge about the random allocation of patients to thei ntervention 1 and 2 group, the researcher was blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691987888
Approval date
2019-07-27, 1398/05/05
Ethics committee reference number
IR.GMU.REC.1398.076
Health conditions studied
1
Description of health condition studied
Breast Fissure
ICD-10 code
N64.0
ICD-10 code description
Fissure and Fistula of Nipple
Primary outcomes
1
Description
Reduction of nipple pain
Timepoint
Before intervention, day 3 and day 8 after intervention
Method of measurement
Using Numerical Rating Scale for measuring pain intensity
Secondary outcomes
1
Description
The improvement of nipple fissures
Timepoint
Before intervention, day 3 and day 8 after intervention
Method of measurement
Measure the severity of damage, by store
Intervention groups
1
Description
intervention group1: In the intervention group1 after breastfeeding 1gr Scrophularia striata cream will be rubbed to the nipple and areola 3 times a day for 7 days
Category
Treatment - Drugs
2
Description
intervention group2: in the intervention group two after breastfeeding 1gr Lanolin cream will be rubbed to the nipple and areola 3 times a day for 7 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Mohaddese Abbaspour
Street address
Ayatolah Bahjat Street, Mashhad, Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1061
Email
Oah.it@mums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohaddese Abbaspour
Street address
the margin of Imam Reza Square, Ibn Sina Street, Mashhad, Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Imamrezahos@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Shahla Khosravan
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
mma_khosravan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691933577
Phone
+98 51 5722 3028
Email
nasirzadeharnz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hamidreza Ebrahimisenu
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691933577
Phone
+98 51 5722 3028
Email
hamid.ebrahimi7050@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohsen Aliakbari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691933577
Phone
+98 51 5722 3028
Email
mohsenaliakbari1998@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