Protocol summary
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Study aim
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effects of purslane on the nipple fissure
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Design
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A randomized, controlled, double-blind, placebo-controlled clinical trial
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Settings and conduct
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This study was performed in health centers of Mashhad. Subjects were randomly assigned into two groups of purslane and lanolin cream and received treatment three times a week.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day,
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Intervention groups
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in groups purslane and lanolin use it on the nipple as amount of a finger, three times a day
immediately after breastfeeding, to cover the entire thin layer of the fissure and continue
treatment up to seven days.
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Main outcome variables
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This study was performed in health centers of Mashhad. Subjects were randomly assigned into two groups of purslane and lanolin cream and received treatment three times a week. The pharmacist put the drug in the same and similar package so that the researcher and the research unit were unaware of the type of treatment.
General information
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Reason for update
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Edit study information according to who criteria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015042421915N1
Registration date:
2017-01-28, 1395/11/09
Registration timing:
retrospective
Last update:
2019-10-16, 1398/07/24
Update count:
1
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Registration date
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2017-01-28, 1395/11/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Mashhad University of Mdical Sciences
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Expected recruitment start date
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2016-10-08, 1395/07/17
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Expected recruitment end date
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2016-12-26, 1395/10/06
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Actual recruitment start date
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2016-10-08, 1395/07/17
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Actual recruitment end date
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2016-12-26, 1395/10/06
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Trial completion date
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2017-11-11, 1396/08/20
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Scientific title
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effects of Purslane Cream on the BreastFissure in Lactating Women: A Clinical Trial
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Public title
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Purslane Cream on the Breast Fissure
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.
Exclusion criteria:
Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. Moreover, other exclusion criteria were abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day, and mother's use ofcold or hot compresses
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
86
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In the present study, multi-stage sampling was performed. In the first stage, sampling was done
in a class. The classes are the five regions of health centers (1-5) of Mashhad, Iran. They were
randomly selected from two classes (center number 3 and 5). The second phase of sampling
was randomly carried out according to the ratio of the patients referred to the thyroid clinic of
centers 3 and 5. In the third stage, among the lactating women referring to these 4 thyroid clinic
centers, firstly, the units of study were selected by inclusion criteria and then placed in two
groups of lanolin and purslane creams on the basis of random numbers. Noteworthy, mothers
along with their children should be routinely visited by their health centers on the third to fifth
day after childbirth to screen and prevent the hypothyroidism and related disorders. In this
regard, these centers were selected to provide more access to lactating women during this
period. Following the selection, required explanations regarding the research design, the
method of research, how to use drugs and the probability of drug allergy were given to them. If
they wished to participate in the research, written consent was obtained in order to observe the
ethical issues, they were assured about the confidentiality of their information and they can
leave the study at any time desired. Using the number cruncher statistical system (NCSS)
software, the samples were randomly assigned to one of the two groups of lanolin and purslane
cream
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Drugs were packed by the pharmacist who un-known regarding the process of the study, in the
same tubes of 30 grams and was coded (A and B).
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-09-18, 1395/06/28
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Ethics committee reference number
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IR.MUMS.REC.1395.300
Health conditions studied
1
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Description of health condition studied
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Nipple fissure
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ICD-10 code
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N64.0
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ICD-10 code description
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Fissure and fistula of nipple
Primary outcomes
1
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Description
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Breast Fissure
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Timepoint
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Before intervention, day 3 and day 8 after intervention
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Method of measurement
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Using Stour scale
Secondary outcomes
1
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Description
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The improvement of nipple fissures
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Timepoint
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Before intervention, day 3 and day 8 after intervention
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Method of measurement
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Measure the severity of damage, by store
Intervention groups
1
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Description
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In the intervention group after breastfeeding 1gr purslane cream will be rubbed to the nipple and areola 3 times a day for8 days.control group after breastfeeding 1grlanolin cream will be rubbed to the nipple and areola 3 times a day for8 days.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Promising effects of Purslane Cream on the Breast Fissure in
Lactating Women: A Clinical Trial
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When the data will become available and for how long
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2018
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To whom data/document is available
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student midwife
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Under which criteria data/document could be used
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systematic review
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From where data/document is obtainable
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azin_niazi65@yahoo.com
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What processes are involved for a request to access data/document
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Articles published in this field will be sent to the applicant.
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Comments
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.