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IRCT20230608058428N1 IRCT 2023-06-22 Mashhad University of Medical Sciences Evaluation of the effect of Elaeagnus angustifolia extract on after-pains The effect of Elaeagnus angustifolia fruit extract capsule on childbirth after-pains among multiparous women 2023-07-23 anticipated 105 Complete https://irct.ir/trial/70610 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible women for the study are divided into 3 groups of Elaeagnus angustifolia fruit extract capsule, placebo and Mefenamic acid by random allocation and enter the study using the random sequence created by the random number table of the site www.randomization.com. In this way, the created random sequence is written on small sheets and kept in a closed envelope, and when each person chooses, the envelope door is opened and they enter each group based on the code (A, B, C), Blinding description: In order to blind groups, the capsules of Elaeagnus angustifolia fruit extract and placebo and mefenamic acid are provided to the researcher by the pharmacist consultant in similar forms (appearance, color and packaging) with three different codes. Therefore, until the end of the study, the research unit and the statistical analyst will not know about the codes related to the Elaeagnus angustifolia fruit extract capsule, placebo and mefenamic acid and which group each of the research units are placed in. 3 after-pains after normal delivery. Intervention 1: Intervention group: Elaeagnus angustifolia will be purchased from centers approved by the Faculty of Iranian and Complementary Medicine, and after grinding, it will be soaked in 70% hydroalcoholic solvent for 2 days. Then, the obtained hydroalcoholic extract is filtered and after removing the solvent by placing it in a dryer, the final extract will be obtained. This dried extract is formulated as a capsule of 500 mg of whole elderberry fruit extract and will be given to mothers 2 hours after delivery, every 6 hours to 24 hours. Intervention 2: Intervention group: (The second intervention group) Using a placebo with similar capsules and cans, made in the pharmacology department of medicinal plants of Mashhad University of Medical Sciences, the capsules contain Avicel powder, which the research units consume 2 hours after delivery, every 6 hours to 24 hours. Intervention 3: Control group: In this group, there will be no intervention on the mothers, and they received mefenamic acid capsules as needed (PRN) according to the routine of Ommolbanin Hospital. In this group, as in other groups, the number of capsules consumed and their after-pain measurement will be evaluated one hour after taking the medicine. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information.
public Seyedeh Parvin Zabeti Asnad Astaneh
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 zabetiAsnadp4001@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Zahra Karimi
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Karimifz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) have the desire to enter the study. age between 18 to 35 years old. At least be literate in reading and writing. The current birth be the second to fourth birth. Normal delivery, singleton and full term. (Based on the ultrasound of the first trimester or last menstrual valid period) The baby be alive and healthy. If there are pains with a score of 4 to 10 based on the pain ruler. Cephalic presentation. The baby's weight should be 2500-4000 grams. (weighing recorded in the baby's file) Not to have any past medical and mental history. (heart disease, chronic Hypertension, and pre-eclampsia, diabetes, kidney and lung disease, autoimmune diseases and all types of neurological and mental diseases) Not to be allergic to Elaeagnus angustifolia. (Symptoms of allergy include: rhinitis, rhinoconjunctivitis, dermatitis) Not to be addicted to drugs, psychotropic substances, alcohol or tobacco. Not to have severe post partum bleeding after delivery.(Bleeding that requires medical measures (other than receiving centocinone) or requiring blood transfer and moving to operating room.) Not having any history of uterine surgery or caesarean section Drug analgesia has not been used to reduce labor pain.(Spinal, Epidural, Entonox gas) Not to have 3 and 4 perineum tears. The first, second, and third stages of labor should be normal.(First stage: no fast or slow progressing labor, no prolonged rupture of membranes (more than 12 hours), second stage: no instrumental labor, no third and fourth degree rupture, third stage: spontaneous exit of the placenta and membranes) 18 years 35 years Female Not intend to continue the research Mother's refusal to take more than one capsule of Elaeagnus angustifolia or placebo The impossibility of continuing to breastfeed the baby (Due to the death of the baby, hospitalization in NICU) Any problem that disturbs the routine care of the mother.(Transferring the mother to the operating room-early discharge before 24 hours-hemorrhage or any obstetric problems of the mother that require treatment.) Z39.2 Encounter for routine postpartum follow-up Treatment - Drugs Placebo Treatment - Drugs Intervention group: Elaeagnus angustifolia will be purchased from centers approved by the Faculty of Iranian and Complementary Medicine, and after grinding, it will be soaked in 70% hydroalcoholic solvent for 2 days. Then, the obtained hydroalcoholic extract is filtered and after removing the solvent by placing it in a dryer, the final extract will be obtained. This dried extract is formulated as a capsule of 500 mg of whole elderberry fruit extract and will be given to mothers 2 hours after delivery, every 6 hours to 24 hours. Intervention group: (The second intervention group) Using a placebo with similar capsules and cans, made in the pharmacology department of medicinal plants of Mashhad University of Medical Sciences, the capsules contain Avicel powder, which the research units consume 2 hours after delivery, every 6 hours to 24 hours. Control group: In this group, there will be no intervention on the mothers, and they received mefenamic acid capsules as needed (PRN) according to the routine of Ommolbanin Hospital. In this group, as in other groups, the number of capsules consumed and their after-pain measurement will be evaluated one hour after taking the medicine. Severity of after pain. Timepoint: After 2 hours after delivery, Elaeagnus angustifolia fruit extract capsule or placebo is given to the mother every 6 hours to 24 hours, and the intensity of after pain is measured one hour after each drug dose. Method of measurement: Painometer-visual analogue scale, which is one of the parts of the painometer tool, will be used to measure pain intensity. Quality of after pain. Timepoint: After 2 hours after delivery, Elaeagnus angustifolia fruit extract capsule or placebo are given to the mother every 6 hours, and the quality of after pain is measured one hour after receiving each drug dose. Method of measurement: To evaluate the quality of pain, the word description scale index, which is one of the parts of the painometer tool, will be used. Mashhad University of Medical Sciences Approved 2023-06-06 Ethics Committee of Mashhad University of Medical Sciences, School of Nursing and Midwifery School of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)