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IRCT20120718010324N62 IRCT 2021-01-24 Tabriz University of Medical Sciences The effect of fenugreek on milk volume and prolactin level in mothers of premature infants The effect of fenugreek on milk volume and prolactin level in mothers of premature infants: A randomized controlled clinical trial 2021-01-28 anticipated 68 Complete https://irct.ir/trial/53201 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be assigned to two groups (one group receiving of oral fenugreek capsule three times a day for two weeks and one group receiving placebo with the same protocol) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1 and using the website www.random.org . To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer, and the drug and placebo will be placed in the same packages numbered sequentially, Blinding description: The participants, researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research. 3 Premature infants. Intervention 1: The intervention group will receive oral capsules containing 500 mg fenugreek powder three times a day (One tablet each time with breakfast, lunch and dinner) made by Pharmacy school of Tabriz University of Medical Sciences. The duration of treatment will be two weeks. Intervention 2: The control group will receive oral capsules containing 500 mg starch three times a day (One tablet each time with breakfast, lunch and dinner) made by Pharmacy school of Tabriz University of Medical Sciences. The duration of treatment will be two weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant data is confidential .
public Mahsa Rouhi
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3478 5229 mshsa.rouhi.mid@gmail.com Tabriz University of Medical Sciences scientific Mojgan Mirghfourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 9876598765 +98 41 3478 5229 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Mothers with preterm infants under 32 weeks on the fifth day after delivery Having a minimum literacy Ability to visit the mother of the hospitalized infant on a daily basis Ability to breastfeed 15 years 49 years Female Allergy to fenugreek Any abnormalities in growth or breast surgery Endocrine problems such as diabetes or thyroid disorder Participate in other interventional study Having asthma P07.3 Other preterm infants Treatment - Drugs Placebo The intervention group will receive oral capsules containing 500 mg fenugreek powder three times a day (One tablet each time with breakfast, lunch and dinner) made by Pharmacy school of Tabriz University of Medical Sciences. The duration of treatment will be two weeks. The control group will receive oral capsules containing 500 mg starch three times a day (One tablet each time with breakfast, lunch and dinner) made by Pharmacy school of Tabriz University of Medical Sciences. The duration of treatment will be two weeks. Milk volume. Timepoint: 7 days after the start of the intervention and 1 day after the end of the intervention. Method of measurement: Using the pump. Serum prolactin levels. Timepoint: One day after the intervention. Method of measurement: Blood test. Infant weight. Timepoint: One day after the intervention. Method of measurement: Scale. Satisfaction of mothers. Timepoint: One day after the intervention. Method of measurement: Checklist. Exclusive breastfeeding. Timepoint: One day after the intervention. Method of measurement: Checklist. Tabriz University of Medical Sciences Approved 2021-01-17 Ethics committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan Tabriz East Azarbaijan Iran (Islamic Republic of)