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IRCT20181203041833N1 IRCT 2019-02-22 Mashhad University of Medical Sciences Comparison of the effect of Boswellia and Lanolin on fissure and pain of the nipple Comparison of the effect of Boswellia and Lanolin ointment on fissure improvment and pain intensity of the nipple 2019-02-10 anticipated 60 Complete https://irct.ir/trial/35712 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized allocation is based on health centers, so that from among the 4 selected health centers on the basis of the lottery, two centers will be allocated to the Lanolin group and two centers will be allocated to the group of Boswellia. Then the clients of each center receive the appropriate treatment. The random allocation of centers to individuals is to prevent the publication of information, Blinding description: The Iranian-made lanolin ointment is prepared in a colorless manner, similar to the mixture of chopped pomace, and then both drugs are placed in the same cans and sizes as the pharmacy mark (a,b) so that the researcher and the unit research does not know its content. Bioequivalence Fissure of nipple. Intervention 1: The intervention group: correct breastfeeding and Boswellia ointment administration amount 1gr are taught (twice a day immediately after breastfeeding for seven days) and rinsed with warm water before breastfeeding.The stour scale will be recorded by the researcher at the stages before the intervention, the third and eighth day after the intervention. Intervention 2: Control group: correct breastfeeding and Lanolin ointment administration amount 1gr are taught (twice a day immediately after breastfeeding for seven days) and rinsed with warm water before breastfeeding.The stour scale will be recorded by the researcher at the stages before the intervention, the third and eighth day after the intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Masoumeh Mobaraki
Ibn Sina Street, School of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 9177116763 +98 51 3859 1511 Mobarakims961@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Golmakani
Ibn Sina Street, Faculty of Nursing and Midwifery, Mashhad
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Golmakanin@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Mothers who suffering from nipple pain and nipple fissure 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 no limit no limit Female The infant uses a pacifier or feeding bottle Mothers who do have any allergy to Boswellia and Lanolin O92.1 Cracked nipple associated with childbirthFissure of nipple, gestational or puerperal Treatment - Drugs Treatment - Drugs The intervention group: correct breastfeeding and Boswellia ointment administration amount 1gr are taught (twice a day immediately after breastfeeding for seven days) and rinsed with warm water before breastfeeding.The stour scale will be recorded by the researcher at the stages before the intervention, the third and eighth day after the intervention Control group: correct breastfeeding and Lanolin ointment administration amount 1gr are taught (twice a day immediately after breastfeeding for seven days) and rinsed with warm water before breastfeeding.The stour scale will be recorded by the researcher at the stages before the intervention, the third and eighth day after the intervention Score of fissuer and nipple pain. Timepoint: Day 3 and 8 after intervention. Method of measurement: The stour scale for fracture and the visual scale of pain for the severity of pain. Mashhad University of Medical Sciences Approved 2018-12-03 National Ethics Committee for Biomedical Research of Mashhad Univercity of Medical Sciences Ibn Sina Street, School of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)