Determining the Effect of Local Form Achillea Millefolium on the Improvement of Nipple Fissure in Lactating Women Referring to Comprehensive Health Centers in Hamadan City in 2018
Design
Clinical trials with control group, randomization
On 84 breast-fed women with Nipple Fissure is performed
Settings and conduct
Women with nipple fissure symptoms referring to comprehensive health centers in 2018 ; If they have conditions for entering the study, they will be included in the study
Participants/Inclusion and exclusion criteria
All lactating women with nipple fissure
Exclusive nutrition with brest feeding
Lack of infant to any abnormalities in the mouth and palate and jaw
Missing mother to any type of nipple abnormality or previous nipple surgery
Mother dose not use any treatment until a week before the study begins
If using a pacifier or milk glass
Taking antibiotic by mother
Intervention groups
Intervention group: Achillea Millefolium tea bag is placed 4 times a day for 14 days on nipple
Control group: A portion of breast milk is placed on the nipple after each breast feeding
Main outcome variables
Severity of nipple fissure; The amount of pain in the fissure of the breast
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040370N1
Registration date:2018-08-01, 1397/05/10
Registration timing:prospective
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Local Effect of Achillea Millefolium and Breast Milk on the Improvement of cracked Nipple in Breast Feeding Women
Public title
The Local Effect of Achillea Millefolium on the Improvement of cracked Nipple
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All lactating women with cracked nipple
Resident of Hamadan
Literacy and at least one telephone line for calling
Suffering of cracked nipple fissure with a minimum score of two from the Stour scale
Has a term new born
Single and having a minimum weight between 2500 and 4000 grams
The absence of maternal addiction and psychological problem or any type of internal or infectious disease
Exclusive nutrition with brest feeding
Lack of infant to any abnormalities in the mouth and palate and jaw
No having any type of nipple abnormality or previous nipple surgery
No using any treatment until a week before the study begins
Exclusion criteria:
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of the participants to the groups is performed by method of allocation concealment. In this way, using the random block 4, the allocation sequence is specified. Then, in the sealed envelopes, the intervention name is written in sequential order, and is numbered accordingly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Fahmide Ave., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-06-26, 1397/04/05
Ethics committee reference number
IR.UMSHA.REC.1397.219
Health conditions studied
1
Description of health condition studied
cracked nipple
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
Improvement of Cracked Nipple
Timepoint
on 4, 8, and 14 days from beginning of the Treatment
Method of measurement
Through Physical Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: compresses of Achillea Millefolium tea bag on nipple for 15 min 4 times a day for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: mother's breast milk 1 ml on nipple for 15 min 4 times a day for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Heath Centers
Full name of responsible person
Sara Abdoli
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Fahmideh Ave., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0717
Email
S_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sara Abdoli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and l Sciences, Shahid Fahmideh AveMidwifery, Hamadan University of Medica.
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Email
Sara.abdoli.m96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh jenabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0496
Email
En.jenabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh jenabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Email
En.jenabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Any analysis on the data is pertinent with the source.
From where data/document is obtainable
Hamadan University of Medical Sciences
What processes are involved for a request to access data/document