Objective; Sore nipples are common during lactation and remains the major reason for failing to establish successful breastfeeding and premature cessation of it.Curcuma Longa is one of the oldest drug plants that has healing effect on wound for its curcumin.The aim of this study is to determine the effectiveness of Curcumin(Curcuma longa Extract) in the treatment of nipple crack's in lactating primiparous women and comparison with the application of expressed breast milk.
Disign;In a randomized clinical trial study that performe in lactating primiparous women in west center of health in Ahwaz ,Iran, sampling is purpose 88 lactating women with sore nipple,that finally will allocate randomly under treatment with two method .Both of groups will educate about correct breastfeeding technique.The reasearcher will complete Storr scale before study,at 3th day and 7th day of study.Analysis of data will performe with parametric and non-parametric testes(by p-value less than 0.05).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082718947N1
Registration date:2014-10-15, 1393/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-15, 1393/07/23
Registrant information
Name
Shaghayegh Sheinizadeh
Name of organization / entity
Islamic Azad University Of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 1321 9387
Email address
sheini90393@iauahvaz.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University of Medical Sciences of Ahvaz.
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-09-20, 1392/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Curcumin(Curcuma longa Extract) Versus Expressed Breast Milk on Nipple Crack's Treatment in lactating Primiparous women
Public title
The effect of Curcumin on nipple crack's treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Proper use of drug; Maternal age over 18 years; Possibility of having a telephone conversation with the patient on days of study.
Exclusion criteria: Fever after delivery; Twin births; Congenital malformations; short frenulum; Infants with abnormal weight; lack of breast feeding; Nipple abnormalities such as Inverted Nipple.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study was designed to allocate patients randomly assigned to two groups treated with curcumin or control group based on odd or even days of research done.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Joondishapoor University Of Medical Sciences
Street address
Ahvaz Joondishapoor University of Medical sciences ,Golestan highway, Ahvaz, Iran.
City
Ahvaz
Postal code
Approval date
2013-02-27, 1391/12/09
Ethics committee reference number
م/ح/22/12944
Health conditions studied
1
Description of health condition studied
Nipple cracks
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
Wound heahling
Timepoint
Third and Seventh days of the intervention
Method of measurement
Examination of patient and determinatin of Stoor scale
Secondary outcomes
1
Description
Side effects
Timepoint
Third and Seventh days after the intervention
Method of measurement
Clinical examination and interview with patients
Intervention groups
1
Description
Intervention group: Curcumin, with medicinal C1386 code was purchased from Orbital Company and then extracted by Methanol to obtain cocentration of 5 percent to use of twice a day after breastfeeding for a week.
Category
Treatment - Other
2
Description
Control group:use one drop from milk of breast twice a day after breastfeeding for a week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
West Center of Health in Ahvaz (Number 4 and 5)
Full name of responsible person
Miss Khani
Street address
Between 15th and 16th Street East, Qian Abad, ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Islamic Azad University of Ahvaz
Full name of responsible person
Somayeh Makvandi
Street address
Islamic Azad University, Farhang Shahr Circle, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
51061900714004
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Islamic Azad University of Ahvaz
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University Of Ahvaz,Iran
Full name of responsible person
Shaghayegh Sheinizadeh Emadi
Position
MS.C in Midwifery.Educator in Department of Nursing and Midwifery,Ahvaz Branch,Islamic Azad Universi
Other areas of specialty/work
Street address
Islamic Azad University, Farhang Shahr Circle, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1321 9387
Fax
Email
Sheini90393@iauahvaz.ac.ir; Emadi_5121@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Of Ahvaz, Iran
Full name of responsible person
Shaghayegh Sheinizadeh Emadi
Position
MS.C in Midwifery, Educator in Department of Nursing and Midwifery, Ahvaz Branc, Islamic Azad Univer
Other areas of specialty/work
Street address
Islamic Azad University, Farhang Shahr Circle, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1321 9387
Fax
Email
Sheini90393@iauahvaz.ac.ir; Emadi_5124@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Of Ahvaz, Iran
Full name of responsible person
Shaghayegh Sheinizadeh Emadi
Position
MS.C in Midwifery, Educator in Department of Nursing and Midwifery, Ahvaz Branch, Islamic Azad Unive
Other areas of specialty/work
Street address
Islamic Azad University, Farhang Shahr Circle, Iran
City
Ahvaz
Postal code
Phone
+98 61 1321 9387
Fax
Email
Sheini90393@iauahvaz.ac.ir; Emadi_5124@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)