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IRCT20161103030684N2 IRCT 2019-05-09 Yasouj University of Medical Sciences The effect of fennel powder on serum prolactin levels in nursing mothers and newborns weight gain. Comparison of the effect of fennel powder on serum prolactin in nursing mothers and weight gain in newborns with the effect of domperidone and placebo 2018-06-10 anticipated 150 Complete https://irct.ir/trial/31683 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation was done with the help of lottery so that the number of people in three groups of intervention and control of the paper was inscribed with the name of the group and placed in a container and by referring each patient one paper randomly selected and the person to the group Written in the paper, Blinding description: The study is done single blind. This means that only patients who received the medication did not know. 3 Comparison the effect of Foeniculum Vulgare Miller ( Fennel) on serum prolacin and newborn weight gain with the effect of Domperidone and placebo. Intervention 1: Intervention group:After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of 1th group received the capsule containing domperidone for 14 days and the level of serum prolactin before and after from the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales. Intervention 2: Intervention group: After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of 2nd group received the capsule containing fennel powder for 14 days and the level of serum prolactin before and after From the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales. Intervention 3: Control group: After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of this group received the placebo capsule for 14 days and the level of serum prolactin before and after from the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because the study has ended before 11.10.1397
public Ali keshtkari
Shahid motahatri Blvd
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3334 6078 a_keshtkari@yahoo.com Yasouj University of Medical Sciences scientific Ali keshtkari
Shahid motahari Blvd
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3334 6078 a_keshtkari@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Mothers have a newborn baby No contraindication for breast feeding Well baby Not having a history of cardiovascular disease in the mother Obtain informed and written consent of patients Birth weight, more than 2500 grams 1 day 2 days Both Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group:After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of 1th group received the capsule containing domperidone for 14 days and the level of serum prolactin before and after from the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales. Intervention group: After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of 2nd group received the capsule containing fennel powder for 14 days and the level of serum prolactin before and after From the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales. Control group: After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of this group received the placebo capsule for 14 days and the level of serum prolactin before and after from the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales. Mother blood serum of prolactin. a weight of newborn,. Timepoint: A blood sample of mothers were taken before and 14 days after using the above drugs. The birth weight, weight of the 14th day and the 28th day were measured. Method of measurement: blood serum levels of prolactin were measured in the laboratory. weight measured using digital scales. New born weight gain. Timepoint: At birth, 14 day and 28 day after birth. Method of measurement: By digital scale. Change in prolactin level. Timepoint: Before taking of drug , 2 weeks later. Method of measurement: By labratory. Yasouj University of Medical Sciences Approved 2018-04-21 Yasuj Research Ethic Committee Blvd shahid mothahari ,Yasuj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)