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IRCT20200105046009N1 IRCT 2020-05-28 Babol University of Medical Sciences Concentrated sweet pomegranate extract by breastfeeding mothers, in jaundice The effect of oral use of pomegranate concentrated juice by mothers on hyperbilirubinemia in neonate under phototherapy 2020-08-22 anticipated 86 Complete https://irct.ir/trial/45857 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by permuted blocks randomization. The size of the blocks is considered to be 4. (2 of each group in each block). Possible arrangements are made up of two groups (drug or control). Then, using the random number table, the numbers 1 to 6 (the number of possible arrangements) are selected and the order of groups of mothers is determined. 3 Neonatal jaundice. Intervention 1: Intervention group: Mothers of neonats with hyperbilirubinemia. After entering the study , concentrated pomegranate extract is used three times a day until hospitalization.Sweet pomegranates are bought in Behshahr region. The fruit species will be identified by the botanist of Nowshahr National Botanical Garden and a sample of it will be kept in the herbarium. The exact scientific name of the pomegranate species and the herbarium number will be obtained. Pomegranate will seed in hygienic condition, then pomegranate juice will be extracted so that the seed is not crushed. Then the pomegranate juice is condensed at a gentle temperature and in the Ben Marie device to some extent (Brix 70) to minimize the possibility of microbial contamination. After preparing the desired extract, microbial contamination control test will be performed and the necessary certificates will be obtained. Quality control tests are also performed for the extract, which includes the following measures: Measurement of water-soluble solids at 20 C (100% gram), pH and total acidity, total tannins, and determination of phenolic compounds in concentrated extract. Pomegranate by HPLC method. Intervention 2: Control group: Mothers of infants who receive only phototherapy. Yes - There is a plan to make this available What will be shared: There is a plan to make this available on request When: After publication of the study, it will be available To whom: For every one who request, including reviewers of the manuscript Conditions: for review articles Where to obtain: for researchers and everyone who evaluates the results How to obtain: E mail to Dr. Mozaffarpur (seyyedali1357@gmail.com) Comments:
public Seyyed Ali Mozaffarpur
Ganj afrooz st.
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 4730 seyyedali1357@gmail.com Babol University of Medical Sciences scientific Seyyed Ali Mozaffarpur
Ganj afrooz st.
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 4730 seyyedali1357@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Mothers of term infants (GA over 37 weeks) serum total bilirubin level of more than 15 mgr / dl over 48 hours of age breastfeed weighing more than 2,500 grams under phototherapy for the treatment of hyperbilirubinemia in the neonatal ward of Babol Shafizadeh Children's Hospital 3 days 28 days Both Hemolytic disease (ABO, Rh incompatibility), G6PD deficiency in neonate Blood exchange in neonate Direct hyperbilirubinemia in neonate hyperbilirubinemia in neonate in the first 24 hours of life Systemic diseases such as liver, heart disease and hypothyroidism in neonate History of use of phenobarbital or other drugs or remedies in neonate sepsis in neonate respiratory distress in neonate Sensitivity to eating pomegranate juice in the mother P59.9 Neonatal jaundice, unspecified Treatment - Drugs Other Intervention group: Mothers of neonats with hyperbilirubinemia. After entering the study , concentrated pomegranate extract is used three times a day until hospitalization.Sweet pomegranates are bought in Behshahr region. The fruit species will be identified by the botanist of Nowshahr National Botanical Garden and a sample of it will be kept in the herbarium. The exact scientific name of the pomegranate species and the herbarium number will be obtained. Pomegranate will seed in hygienic condition, then pomegranate juice will be extracted so that the seed is not crushed. Then the pomegranate juice is condensed at a gentle temperature and in the Ben Marie device to some extent (Brix 70) to minimize the possibility of microbial contamination. After preparing the desired extract, microbial contamination control test will be performed and the necessary certificates will be obtained. Quality control tests are also performed for the extract, which includes the following measures: Measurement of water-soluble solids at 20 C (100% gram), pH and total acidity, total tannins, and determination of phenolic compounds in concentrated extract. Pomegranate by HPLC method Control group: Mothers of infants who receive only phototherapy Neonates bilirubin levels in blood. Timepoint: daily after hospitalization. Method of measurement: Bilirubin is checked by Diazo (photometeric) method with Darman Faraz Kave kits made in Iran. The duration of phototherapy. Timepoint: The days of phototherapy for neonate. Method of measurement: The duration (days) of phototherapy. The duration of hospitalization. Timepoint: the duration of hospitalization of neonates. Method of measurement: The duration (days) of phototherapy. The need for blood transfusions. Timepoint: during hospitalization. Method of measurement: Is blood transfusions performed or not?. Babol University of Medical Sciences Approved 2020-03-14 Ethics committee of Babol University of Medical Sciences Sargord Ghasemi Ave Babol Mazandaran Iran (Islamic Republic of)