Comparison of the effectof Boswellia and Lanolin ointment on fissure improvment and pain intensity of the nipple
Design
A triple- blind clinical trial with parallel groups on 60 eligible breastfeeding women will be performed and the random allocation of the groups will be done by randomization sequencing by the SPSS software.
Settings and conduct
In Mashhad health selected centers (2,5), the right way of breastfeeding and using medicine (2 times per day, immediately after breastfeeding for seven days (a week), will be taught to two group, and before the second breastfeeding.The breast should be washed with warm water.The Stoure score before the intervention of third day and eighth day will be registered by researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all lactating women with term and healthy infants who suffering from cracked and nipple pain. Exclusion criteria: mothers whose infant uses a pacifier or feeding bottle, mothers who have any allergies to Boswellia and Lanolin
Intervention groups
Intervention group: routine care and education on the correct way of breastfeeding, topical application of Boswellia ointment twice a day after breastfeeding for up to seven days, washing breast with warm water before breastfeeding.
Control group: routine care and education on the correct way of breastfeeding, topical application of Lanolin ointment twice a day after breastfeeding for up to seven days, Washing breast with warm water before breastfeeding
Main outcome variables
Fissure and nipple pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181203041833N1
Registration date:2019-02-22, 1397/12/03
Registration timing:registered_while_recruiting
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Masoumeh Mobaraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
mobarakims961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-10, 1397/11/21
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Boswellia and Lanolin ointment on fissure improvment and pain intensity of the nipple
Public title
Comparison of the effect of Boswellia and Lanolin on fissure and pain of the nipple
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who suffering from nipple pain and nipple fissure
Iranian
Literate
Singleton birth
Term and healthy infant and exclusively breast fed
Infant weight 2500 to 4000 grams
Infant without any mouth or palate or jaw or face anomaly
Mother without any identified mental disease
Mother without any nipple malformation (flat or inverted nipples or any nipple malformation which is followed by burning or any history of nipple and areola operation in childhood)
Mothers don't suffer from known background diseases such as diabetes or any kind of internal_surgical diseases
Exclusion criteria:
The infant uses a pacifier or feeding bottle
Mothers who do have any allergy to Boswellia and Lanolin
Age
No age limit
Gender
Female
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized allocation is based on health centers, so that from among the 4 selected health centers on the basis of the lottery, two centers will be allocated to the Lanolin group and two centers will be allocated to the group of Boswellia. Then the clients of each center receive the appropriate treatment. The random allocation of centers to individuals is to prevent the publication of information.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The Iranian-made lanolin ointment is prepared in a colorless manner, similar to the mixture of chopped pomace, and then both drugs are placed in the same cans and sizes as the pharmacy mark (a,b) so that the researcher and the unit research does not know its content
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research of Mashhad Univercity of Medical Sciences
Street address
Ibn Sina Street, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.068
Health conditions studied
1
Description of health condition studied
Fissure of nipple
ICD-10 code
O92.1
ICD-10 code description
Cracked nipple associated with childbirthFissure of nipple, gestational or puerperal
Primary outcomes
1
Description
Score of fissuer and nipple pain
Timepoint
Day 3 and 8 after intervention
Method of measurement
The stour scale for fracture and the visual scale of pain for the severity of pain
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: correct breastfeeding and Boswellia ointment administration amount 1gr are taught (twice a day immediately after breastfeeding for seven days) and rinsed with warm water before breastfeeding.The stour scale will be recorded by the researcher at the stages before the intervention, the third and eighth day after the intervention
Category
Treatment - Drugs
2
Description
Control group: correct breastfeeding and Lanolin ointment administration amount 1gr are taught (twice a day immediately after breastfeeding for seven days) and rinsed with warm water before breastfeeding.The stour scale will be recorded by the researcher at the stages before the intervention, the third and eighth day after the intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No.5 of Mashhad
Full name of responsible person
Dr BratAli Arab Nejad
Street address
11 West Saba Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9153913153
Phone
+98 51 3673 7004
Email
Arabnejadba1@mums.ac.ir
2
Recruitment center
Name of recruitment center
Health Center No. 2 of Mashhad
Full name of responsible person
Dr.Ali Asghar Mahmoudi
Street address
Vahdat Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9153913153
Phone
+98 51 3368 3000
Email
Mahmoudia1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Golmakani
Street address
Ibn Sina Street, School of Nursing and Midwifery, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9913197319
Phone
+98 51 3859 1511
Email
GolmakaniN@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Mobaraki
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ibn Sina Street, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9177116763
Phone
+98 51 3859 1511
Email
Mobarakims961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Golmakani
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ibn Sina Street, Faculty of Nursing and Midwifery, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Golmakanin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoume Mobaraki
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ibn Sina Street, Faculty of Nursing and Midwifery, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Mobarakims961@mums.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
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