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IRCT20120122008801N23 IRCT 2019-12-30 Shahid Beheshti University of Medical Sciences Effect of Fennel, Fenugreek and their Combination with Honey on Lactation A Comparative Study on the Effect of “Honey and Fennel”, “Honey and“Fenugreek”, “Fennel”, and “Fenugreek” on Quality of Breastfeeding 2020-01-21 anticipated 200 Complete https://irct.ir/trial/44309 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, the researchers, after obtaining the necessary permits for the research, will perform sampling in two selected health centers of Tehran (Nader and Sahebzaman). In these centers, sampling is done by random allocation. Participants, after completing a written consent form, will complete a personal information questionnaire, and a breastfeeding success questionnaire. The infant's characteristics are also determined and weight, height and head circumference of the baby are measured. They were then randomly divided into four groups of 50 each. Includes: 1- Fennel and honey composition group 2- Fenugreek and Fennel composition group 3- Fennel group 4- Fenugreek group. These four groups take the herbal medicine in drops. Each of the four groups consumed 30 drops daily in three servings for four weeks. During the intervention, infant growth information will be assessed by measuring height, weight, head circumference and lactation success rate by completing the lactation success questionnaire every two weeks. Then the data obtained in three stages (before the intervention and during the intervention during the two follow-up intervals) were used for statistical analysis and comparison by SPSS software. Drug side effects are also determined at the end of the intervention, Randomization description: Randomization is performed by simple randomization using a random number table. 200 participants are divided into four groups of 50 people by simple randomization method. Includes: 1- Fennel and honey composition group, 2- Fenugreek and Fennel composition group, 3- Fennel group, 4- Fenugreek group, Blinding description: Participants in all four groups will receive the same medication (in the form of a drop). These drugs are coded by the manufacturer of the drugs. These codes are not clear to the participants, researchers, and controllers. At the end, the codes will be specified for data analysis. 3 The success of lactation. First Intervention group: Fennel and honey composition group, Second intervention group: Fenugreek and fennel combination group, Third intervention group: Fennel group, Fourth intervention group: Fenugreek group.p:. Yes - There is a plan to make this available What will be shared: Protocol and data files When: After publishing the article To whom: For Journal reviewers and the readers of the article if they need Conditions: If they asked Where to obtain: Midwifery and Reproductive Health Rese4arch Center Shahid Beheshti University of Medical Sciences How to obtain: email to researchers Comments:
public Masoumeh Simbar
Cross of Hashemi Highway and Valiasr Avenue
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8820 2112 msimbar@gmail.com Shahid Beheshti University of Medical Sciences scientific Masoumeh Simbar
Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences , Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital
Tehran Iran (Islamic Republic of) 1996835119 0098 21 888202512 msimbar@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Healthy Women No smoking House wives Exclusive breastfeeding The mother has a normal body mass index (19.8-26 kg / m 2) During the first 1 to 5 months after delivery There is a milk deficiency, despite the correct method of breastfeeding The woman should not have breast problems such as abscesses, nipple dislocations, and low or non-glandular tissue of the breast The mother should not take any drugs that interfere with the production of milk and antibiotics Recent history of normal delivery of a single-term baby weighing between 2.5 and 4 kg The infant has no malformations, illness, or malnutrition problem requiring hospitalization no limit no limit Female Any mental illness in the mother Any physical illness that disrupts breastfeeding, such as liver disease, cancer and mammalian problems in the mother Mother taking dopamine antagonist drugs (such as domperidone, metoclopramide, rospridone, phenothiazine) The mother stops breastfeeding for any reason Treatment - Other First Intervention group: Fennel and honey composition group, Second intervention group: Fenugreek and fennel combination group, Third intervention group: Fennel group, Fourth intervention group: Fenugreek group.p: Lactation. Timepoint: Measurement of infant's weight, height, and head circumference and information on lactation success at baseline (before beginning) and 14 and 28 days after taking compounds in all four groups. Method of measurement: Measuring infant growth by measuring infant's weight, height and circumference, measuring lactation success by completing the Lactation Success Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2019-11-04 کمیته اخلاق دانشکده های داروسازی، پرستاری و مامایی- دانشگاه علوم پزشکی شهید بهشتی Iran National commitee for Ethics in Biomedical Research Tehran Tehran Iran (Islamic Republic of)