]>
IRCT20220816055724N3 IRCT 2022-12-17 Arak University of Medical Sciences The Effect of Astragalus fasciculifolius and Phenytoin Cream on pain and episiotomy wound healing Investigating the effect of Astragalus fasciculifolius and Phenytoin Cream on pain and episiotomy wound healing in primiparous women 2022-09-23 anticipated 120 Complete https://irct.ir/trial/65311 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study with a sample size of 120 people, to balance the number of samples allocated in each group, the participants will be randomly placed into three groups of 40 people (two intervention groups and one control group) by using the block permutation randomization. We need 20 blocks of 6 for 120 people. We select these blocks using random allocation software, which is capable of generating a random sequence using the blocking method, Blinding description: Astragalus fasciculifolius plant cream and placebo cream based on vaseline, prepared by a traditional medicine pharmacist and phenytoin cream prepared by Amin Pharmaceutical Company , at the traditional medicine research center, will be filled in similar white tubes ( with a capacity of 60 cc) as named as A, B and C and will be available to the researcher to conduct research. The researcher, the participant, the outcome assessor , the results analyzer and the data safety and monitoring committee will not know the contents of the tubes until the end of the review and announcing the results. 3 Condition 1: Pain severity. Condition 2: Wound healing. Intervention 1: Intervention group 1; Astragalus fasciculifolius Cream 10%: This herbal cream (Astragalus fasciculifolius plant), based on Vaseline and 10% active substance concentration, will be made by a traditional medicine doctor in a traditional medicine laboratory. This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment. Intervention 2: Intervention group 2; Phenytoin Cream 1%: Phenytoin cream 1% is produced by Amin Pharmaceutical Company. It is filled in a 60 mg white tube by a traditional medicine doctor for the purpose of blinding (like the tubes of other groups). This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment. Intervention 3: Control group: Placebo Cream: The Vaseline cream is filled in a 60 mg white tube by a traditional medicine doctor for the purpose of blinding (like the tubes of other groups).This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr Fereshteh Farzanazar
Mojtame Paiambarazam, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 38481-7-6341 +98 86 3417 3520 dr.faezanazar@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Mehdi Salehi
Mojtame Paiambarazam, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 38481-7-6341 +98 86 3417 3520 dr.salehi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Normal pregnancy and delivery primiparous Age between 15-45 Having at least reading and writing literacy Body mass index (after delivery) between 18.5-30 kilograms per square meter 15 years 45 years Female Gestational age below 37 or above 42 weeks Multiple pregnancy Fetus Malpresentation Suffering from diseases that interfere with wound healing such as: anemia, infection and perineum wounds, diabetes, High blood pressure, diseases of skin, heart, kidney, lung , coagulation disorder, immunodeficiency, hemophilia, disorder of connective tissue, depression, malnutrition, mental illnesses, cancer) Using drugs effective on wound healing such as: anticoagulants, antidepressants, antiepileptics), glucocorticoids, immune system suppressors, antibiotics, narcotics and psychotropic drugs, chemotherapy Rupture of Amionitic membran more than 18 hours Instrumental vaginal delivery or non-medial or lateral episiotomy incision Non spontaneous removal of the placenta History of previous injury or surgery or visible lesions in the perineum such as: genital warts, hemorrhoids Alcohol drinking or smoking Persistent constipation (according to the mother statement ) G89.18 O90.1 Other acute post procedural pain Disruption of peritoneal obstetric wound Treatment - Drugs Treatment - Drugs Placebo Intervention group 1; Astragalus fasciculifolius Cream 10%: This herbal cream (Astragalus fasciculifolius plant), based on Vaseline and 10% active substance concentration, will be made by a traditional medicine doctor in a traditional medicine laboratory. This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment. Intervention group 2; Phenytoin Cream 1%: Phenytoin cream 1% is produced by Amin Pharmaceutical Company. It is filled in a 60 mg white tube by a traditional medicine doctor for the purpose of blinding (like the tubes of other groups). This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment. Control group: Placebo Cream: The Vaseline cream is filled in a 60 mg white tube by a traditional medicine doctor for the purpose of blinding (like the tubes of other groups).This cream is applied to the episiotomy area in the amount of 5 cc, every 8 hours, in the first 10 days after delivery. It is performed on the first day by the researcher and then on the following days by the mother (after training the mother). The mother will also receive routine treatment. Pain. Timepoint: Days1, 5 and 10 after delivery. Method of measurement: Visual analog scale (VAS). Episiotomy wound healing. Timepoint: Days1, 5 and 10 after delivery. Method of measurement: Reeda Questionnaire. Drug side effect. Timepoint: Days 5 and 10 after delivery. Method of measurement: questionnaire. Arak University of Medical Sciences Approved 2022-06-26 Ethics Committee of Arak University of Medical Sciences Arak University Of Medical Science, Almalhoda Avenue, Arak, Iran Arak Markazi Iran (Islamic Republic of)