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The effect of Ziziphus Jujube fruit lotion improvement of nipple fissure

Phase 3
Conditions
ipple fissure.
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Registration Number
IRCT2015121225490N1
Lead Sponsor
Sponsor 1 research and technology department of Shahid Beheshti University of Medical Sciences, Teh
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
100
Inclusion Criteria

Entry criteria: Mothers suffering from nipple pain and nipple fissure who; more than 18 years old; 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; mothers who do not have any allergy to Ziziphus Jujube fruit lotion. Excluding Criteria: During the study, the infant uses a pacifier or feeding bottle;The mother makes use of milking machine or plastic nipple; During the study, the infant gets infected to a disease; During the study, allergy to Ziziphus Jujube fruit lotion occurs; During the study the mother uses antibiotic;The mother gets infected to mastitis, breast abscesses or fungal infection of the breast; The mother does not desire to continue cooperation; Use of the proposed treatment less than five times a day; Use of the other treatments by the mother.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction of nipple pain. Timepoint: Before intervention, day 7 and day 14 after intervention. Method of measurement: Using Numerical Rating Scale for measuring pain intensity.;Reduction of nipple wound discharge. Timepoint: Before intervention, day 7 and day 14 after intervention. Method of measurement: Visual analog.;The improvement of nipple fissures. Timepoint: Before intervention, day 7 and day 14 after intervention. Method of measurement: Measure the severity of damage, by Amir scale.
Secondary Outcome Measures
NameTimeMethod
Side effects of ziziphus jujube fruit lotion. Timepoint: Before intervention, day 7 and day 14 after intervention. Method of measurement: Before intervention, day 7 and day 14 after intervention.
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