Protocol summary
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Study aim
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Determine the Effect of Scrophularia Striata on Breast Fissure of Lactating Women
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Design
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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.
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Settings and conduct
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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 .
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Reduction of nipple pain
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-03-31, 1398/01/11
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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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Expected recruitment start date
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2019-04-09, 1398/01/20
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Expected recruitment end date
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2019-05-10, 1398/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect of Scrophularia Striata Plant on Breast Fissure of Lactating women
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Public title
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The Effect of Scrophularia Striata on Breast Fissure of Lactating women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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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:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using the number cruncher statistical system (NCSS) software, the samples will randomly assign to one of the two groups of Scrophularia striata and lanolin.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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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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2019-07-27, 1398/05/05
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Ethics committee reference number
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IR.GMU.REC.1398.076
Health conditions studied
1
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Description of health condition studied
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Breast 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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Reduction of nipple pain
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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 Numerical Rating Scale for measuring pain intensity
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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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
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Category
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Treatment - Drugs
2
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Description
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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.
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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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Gonabad 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available