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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201403116709N16 |
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Date of registration:
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2014-10-06 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of Lanolin, Peppermint and Dexpanthenol on traumatic nipple in lactating mothers
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Scientific title:
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Comparing the effect of Lanolin, Peppermint and Dxpanthenol on treatment of traumatic nipple in lactating mothers: a randomized double-blind controlled trial |
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Date of first enrolment:
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2014-05-31 |
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Target sample size:
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126 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/7129 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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kazhal Masoudin
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Address:
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Faculty of Nursing and Midwifery, South Shariati Street,Tabriz
5177854616
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1447 4467 |
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Email:
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K_masoudin@yahoo.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Name:
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Mahnaz Shahnazi
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Address:
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Faculty of Nursing and Midwifery, South Shariati Street, Tabriz
51745347
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1479 6770 |
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Email:
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mshahnazi@tbzmed.ac.ir |
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Affiliation:
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Tabriz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: single birth; exclusive breastfeeding; term infant; infants less than 2 months of age; earn a minimum score 1 on a scale of NTS and NSRS; mother's lack of sensitivity to Lanolin, Peppermint and Dexpanthenol; 2500-4000 grams birth weight; the absence of abnormal nipple (flat, depressed).
Exclusion criteria: infant with tongue and teeth abnormalities; baby use pacifier, glass and plastic nipple; mother with history of mental illness
Exclusion criteria:
Age minimum:
18 years
Age maximum:
40 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Other disorder of breast
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Cracked nipple.
Other disorder of breast
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Intervention(s)
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Intervention 1: Control group: Lanolin cream with trade name of Lanolin made by Iran Nazhoo Company, containing purest Lanolin and no preservative and any other additives that for 2 weeks 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied. Intervention 2: Intervention group 1: Peppermint cream, made by pharmacy faculty in Tabriz, containing Carbopol, Methyl paraben, Tritanolamin and Glycerin with 0.2% Peppermint oil added to it that for 2 weeks, 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied. Intervention 3: Intervention group 2: Dexpanthonel cream with trade name of Panthoderm made by Caspian Company, containing Pantothenic acid for 2 weeks 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied.
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Intervention group 1: Peppermint cream, made by pharmacy faculty in Tabriz, containing Carbopol, Methyl paraben, Tritanolamin and Glycerin with 0.2% Peppermint oil added to it that for 2 weeks, 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied.
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Control group: Lanolin cream with trade name of Lanolin made by Iran Nazhoo Company, containing purest Lanolin and no preservative and any other additives that for 2 weeks 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied.
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Intervention group 2: Dexpanthonel cream with trade name of Panthoderm made by Caspian Company, containing Pantothenic acid for 2 weeks 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied.
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Treatment - Drugs
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Primary Outcome(s)
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Nipple trauma injury. Timepoint: Before the intervention and two weeks after intervention. Method of measurement: Champion scale.
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Secondary Outcome(s)
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Nipple pain. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: pain Sttor scale.
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Source(s) of Monetary Support
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Research dupty of Tabriz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Tabriz University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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