]>
IRCT20160523028008N25 IRCT 2022-08-16 Hamedan University of Medical Sciences The effect of Anahil 500 (bromelain 500) and vitamin C on episiotomy wound healing The effect of Anahil 500 (bromelain 500) and vitamin C on episiotomy wound healing in primiparous women 2022-08-23 anticipated 140 Complete https://irct.ir/trial/65071 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method will be used to implement random assignment. In this way, 140 consecutive (from 1 to 1400) will be written individually on paper and will be placed in a container. Then, each of the participants in the trial is asked to randomly select one of these 140 numbers in the container containing the numbers. Individuals who have selected numbers from 1 to 35 will be assigned to group A ("Intervention group 1") and those who have chosen numbers 36 to 70 to group B ("Intervention group 2") those who have selected numbers 71 to 106 to group C ("Intervention group 3") and those who have selected numbers 107 to 1400 to group d (control group), Blinding description: The researcher will be unaware of the type of intervention. The physician examining the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind. 2-3 Episiotomy. Intervention 1: Intervention group: bromelain 500mg (one tablet) (Salamat Permon Amin) 2 hours after delivery three times a day along with oral vitamin C 100mg one tablet (Elixir Pharmaceuticals) for seven days after delivery. Intervention 2: Intervention group: bromelain 500mg (one tablet) (Salamat Permon Amin) 2 hours after delivery three times a day for seven days. Intervention 3: Intervention group: oral vitamin C 100mg one tablet (Elixir Pharmaceuticals) for seven days after delivery. Intervention 4: Control group: Placebo, one tablet, from 2 hrs after delivery, three times daily for seven days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is not a plan to make this available
public Shahla Nasrolahi
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0717 Dr-nasrolahi@yahoo.com Hamedan University of Medical Sciences scientific fatemeh salmani andabili
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0717 Salmani.fatemeh5@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 40 years Gestational age between 37 to 42 weeks single pregnancy cephalic presentation Normal vaginal delivery newborn Weight between 2500 to 4000 grams Medio-lateral episiotomy with 4-3 cm lengt Education level at least the fifth grade, body mass index: 19.8-26 kg/m2 Cervical dilation 3-5 cm 18 years 40 years Female Diseases affecting wound healing Smoking and drug abuse Consumption of drugs affecting wound healing (glucocorticoids, anti-coagulatives, immune system suppressants, antibiotics or chemotherapy agents) abortion premature rupture of membranes having symptoms indicative of infection Anemia abnormal first, second or third delivery stage dead baby 090 Complications of the puerperium, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: bromelain 500mg (one tablet) (Salamat Permon Amin) 2 hours after delivery three times a day along with oral vitamin C 100mg one tablet (Elixir Pharmaceuticals) for seven days after delivery. Intervention group: bromelain 500mg (one tablet) (Salamat Permon Amin) 2 hours after delivery three times a day for seven days. Intervention group: oral vitamin C 100mg one tablet (Elixir Pharmaceuticals) for seven days after delivery. Control group: Placebo, one tablet, from 2 hrs after delivery, three times daily for seven days. Pain. Timepoint: 2 hrs after delivery, 24 hrs after delivery, 1 hr after consumption of initial dose. Method of measurement: VAS scale. Wound healing. Timepoint: 3th, 7th, and 14th day after deliver. Method of measurement: REEDA scale. Hamedan University of Medical Sciences Approved 2022-07-23 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)