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IRCT20140525017827N5 IRCT 2019-07-28 Shiraz University of Medical Sciences Comparison Between Myrrh, Boswellia And Betadine For Repair of Episiotomy Comparison Between Commiphora Myrrh, Boswellia Spp. And Betadine Solution For Repair of Episiotomy After Normal Vaginal Delivery 2019-07-29 anticipated 90 Complete https://irct.ir/trial/28614 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Formulation A, B and C have been administered in the similar bottles, are made by the pharmacists with the same appearance and characteristics and will be given to our colleague drug distributor in the form of A or B or C. The treatment allocation list is already designed on Block Balanced Randomization Method by the computer software. 1 (A), 2 (B), 3 (B), 4 (B), 5 (A),……. Any eligible patient will be given a 1 to 90 code after obtaining informed consent in order to visit the clinic and based on above block, they receive A or B or C drug. The drug distributor doesn’t have a role in the treatment plan and data analysis. The patients, researcher, data analyzer are not aware of the type of treatment for each patient. Finally, the patients will be followed by their own codes, Blinding description: Formulation A, B and C have been administered in the similar bottles, so patients and researchers were unable to detect which one was Myrrh, Boswelia and betadine. Our nurse colleague in this study in Hafez and Zeinabie hospitals delivered formulations to the participants of the study according to the randomized block table. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified. 3 Episiotomy wound healing. Intervention 1: Intervention group: Group A will receive herbal formulation based on Myrrh, Hydro alcoholic extract of Myrrh resin prepared by 1: 5 ratio (90% ethanol was used). Each patient will use 15 cc in 5 liter of water for 10 minutes, twice a day for a week. Intervention 2: Intervention group: Group B will receive herbal formulation based on Boswellia, Hydro alcoholic extract of Boswellia resin prepared by 1: 5 ratio (90% ethanol was used). Each patient will use 15 cc in 5 liter of water for 10 minutes, twice daily for a week. Intervention 3: Control group: Patients in group C will use Betadine solution, 15 cc in 5 liter of water for 10 minutes, twice daily for a week. Yes - There is a plan to make this available What will be shared: En IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient When: IPD: 2019 Ethic form: 2019 To whom: IPD: Researcher & Patient Ethic form: Patient Conditions: IPD: Ethic form: Awareness of test results Where to obtain: IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences How to obtain: IPD: Vice chancellery Ethic form: Vice chancellery Comments:
public Marya Aghdaki
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3233 2365 maryam.aghdaki@yahoo.com Shiraz University of Medical Sciences scientific Nasrin Asadi
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 nsasadi2002@yahoo.ca Shiraz University of Medical Sciences Iran (Islamic Republic of) Who have normal vaginal delivery with mediolateral episiotomy. parity 1 Normal body mass index (BMI) before pregnancy (less than 25). Gestational age 37 to 42 weeks Available for several post partum visits 18 years 41 years Female Mothers who have complications immediately after devilry instrumental delivery 3º or 4º degree perineal laceration who have history of medical problems like diabetes mellitus, hypertention, anemia, Rheumatology disease... Previous history of perineorrhaphy perineal hematoma post delivery fever upper than 38 degree of centigrade smokers infection of the episiotomy site prolonged rupture of membranes O90.1 Disruption of perineal obstetric wound Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Group A will receive herbal formulation based on Myrrh, Hydro alcoholic extract of Myrrh resin prepared by 1: 5 ratio (90% ethanol was used). Each patient will use 15 cc in 5 liter of water for 10 minutes, twice a day for a week. Intervention group: Group B will receive herbal formulation based on Boswellia, Hydro alcoholic extract of Boswellia resin prepared by 1: 5 ratio (90% ethanol was used). Each patient will use 15 cc in 5 liter of water for 10 minutes, twice daily for a week. Control group: Patients in group C will use Betadine solution, 15 cc in 5 liter of water for 10 minutes, twice daily for a week. Wound healing. Timepoint: The 0, 2 , 7 day after delivery. Method of measurement: visiting the paients and filling " REEDA" questionnaire by the researcher. Shiraz University Of medical Science Approved 2019-02-27 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz Shiraz Fars Iran (Islamic Republic of)