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IRCT20240609062066N1 IRCT 2024-08-31 Rafsanjan University of Medical Sciences the effect of Nigella sativa ( black seed) capsules on the breastfeeding pattern of women Investigating the effect of use Nigella sativa ( black seed) capsules on the breastfeeding pattern of women 2024-08-20 anticipated 90 Complete https://irct.ir/trial/78317 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, a random sequence with a size of 4 will be created using the random blocking method on the web (using the computer program Createa blocked randomisation list with the link https://www.sealedenvelope.com/simple-randomiser/v1/lists). The method of concealment is by using non-transparent sealed envelopes. In this way, a random sequence is first created using the mentioned method, then 90 envelopes are prepared and each of the random sequences is on a registration card. and the cards are placed in the mail envelopes in order after the start of sampling based on the entry criteria, one of the mail envelopes is opened in order and the participant group is revealed and this procedure continues until the end of the sampling, Blinding description: Black seed capsules and placebo will not have any difference in appearance. The envelopes of the intervention group with black capsules will be prepared with the same packaging as the envelopes of the control group, and code A or B will be written on the envelopes. 3 . Intervention 1: Intervention group: Black seed powder is prepared in the form of capsules containing 250 mg of black seed powder by Barij Essence Company, and the capsules are used three times a day after breakfast, lunch and dinner for 12 days from the third day of birth. Intervention 2: Control group: The ingredient used is cellulose compounds, which are prepared in the form of 250 mg capsules by Barij Essence Company, and the capsules are used three times a day after breakfast, lunch and dinner for 12 days from the third day of birth. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 1 month after the results are published To whom: The data will be available to researchers working in academic and scientific institutions as well as to people who are also engaged in industry and can apply to receive them. Conditions: There are no other conditions Where to obtain: Niloofar Shafipoor Phone: 09011079452, 09932665020 Address: left side, second door, North Keshavarzi Alley 18, Keshavarzi Ave, Jiroft ,Kerman Gmail: shafipoorniloofar024@gmail.com Pouran Allahbakhshi Phone: 09138911459 Address: Faculty of Nursing and Midwifery, Parastar Ave, Rafsanjan, Kerman Rafsanjan University of Medical Sciences, Elkhebal Square, Kerman, Rafsanjan How to obtain: E-mailing or calling the responsible people, answering immediately after receiving the e-mail or answering the phone call Comments:
public Niloofar Shafipoor
left side, second door, North Keshavarzi Alley 18, Keshavarzi Ave.
Jiroft Iran (Islamic Republic of) 7861954356 +98 34 4321 7322 shafipoorniloofar024@gmail.com Rafsanjan University of Medical Sciences scientific Niloofar Shafipoor
left side, second door, North Keshavarzi Alley 18, Keshavarzi Ave.
Jiroft Iran (Islamic Republic of) 7861954356 +98 34 4321 7322 shafipoorniloofar024@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Mothers aged 18-45 Full-term and single-term babies The baby's weight is between 2500-4000 grams The ability to suck the breast Low risk pregnancy The mother's body mass index is greater than or equal to 18.5 kg/m2 Desire to breastfeed 18 years 45 years Female Anatomical problems of the newborn Abnormal maternal bleeding after delivery Receiving herbal or chemical milk-enhancing drug by the mother before starting the study Mental illness Liver disease and cancer Thyroid disease and levothyroxine use Treatment - Drugs Treatment - Drugs Intervention group: Black seed powder is prepared in the form of capsules containing 250 mg of black seed powder by Barij Essence Company, and the capsules are used three times a day after breakfast, lunch and dinner for 12 days from the third day of birth. Control group: The ingredient used is cellulose compounds, which are prepared in the form of 250 mg capsules by Barij Essence Company, and the capsules are used three times a day after breakfast, lunch and dinner for 12 days from the third day of birth. Feeding babies with breast milk (number of babies fed with breast milk). Timepoint: On the fifth, tenth and fifteenth day of birth. Method of measurement: During the researcher's phone call with the participants and asking how to feed the baby and completing the phone checklist. Feeding babies with breast milk plus liquids except formula (number of babies fed with breast milk plus liquids except formula). Timepoint: On the fifth, tenth and fifteenth day of birth. Method of measurement: During the researcher's phone call with the participants and asking how to feed the baby and completing the phone checklist. Feeding babies with breast milk plus formula (number of babies fed with breast milk plus formula). Timepoint: On the fifth, tenth and fifteenth day of birth. Method of measurement: During the researcher's phone call with the participants and asking how to feed the baby and completing the phone checklist. Feeding babies with formula (number of babies fed with formula). Timepoint: On the fifth, tenth and fifteenth day of birth. Method of measurement: During the researcher's phone call with the participants and asking how to feed the baby and completing the phone checklist. . Timepoint: . Method of measurement: . Rafsanjan University of Medical Sciences Approved 2024-07-30 Ethics committee of Rafsanjan University of Medical Sciences Research and Technology Vice-Chancellor, Building No. 3, Central Organization of Rafsanjan University of Medical Sciences,Imam Ali Blvd.Rafsanjan, Rafsanjan Kerman Iran (Islamic Republic of)