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IRCT20100130003226N21 IRCT 2024-01-03 Shahid Beheshti University of Medical Sciences Effect of valerian capsule on postpartum pain Investigating the effect of Valeriana Officinalis Capsule on postpartum pain 2024-01-21 anticipated 70 Complete https://irct.ir/trial/69190 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random assignment to intervention and control groups: ​The function of random numbers will be used to randomize and assign people to groups. Randomization will be done using Excel software and the list of random numbers will be the total number of samples, which will be recorded in front of each drug code number A or B. Before starting the study, the capsules will be placed in similar envelopes by the drug consultant, and code A or B will be recorded on each envelope. 4 capsules will be placed in each envelope.There are 4 medicine capsules in one envelope and 4 placebo capsules in the next envelope. after the start of the study, based on the list of random numbers and specified groups, the envelopes of medicines will be provided by the researcher to the research units in the order of entry into the study. Mefenamic acid routine treatment will be given to both groups, Blinding description: When preparing medicine and placebo, the pharmacist gives a code of one or two to their cans, and the code will remain hidden for the researcher, research unit and data analyst until the end of the analysis. 3 postpartum pain. Intervention 1: Intervention group: 2 hours after delivery, every 8 hours for 24 hours, a Valerian capsule containing 500 mg of its powder is given, and one hour after each intervention, if the pain does not improve, a 250 mg Mefenamic acid capsule is given. This capsule will produce at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Intervention 2: Control group: 2 hours after delivery, every 8 hours for 24 hours, a placebo capsule containing 500 mg of starch powder is given, and one hour after each intervention, if the pain does not improve, a 250 mg Mefenamic acid capsule is given. This capsule will produce at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. 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 Dr.Mahrokh Dolatian
School of Nursing and Gynecology Department, In front of Shaheed Rajaee Heart Hospital, The intersection of Niayesh, Vali asr street, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 mhdolatian@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr.Mahrokh Dolatian
School of Nursing and Gynecology Department, In front of Shaheed Rajaee Heart Hospital, The intersection of Niayesh, Vali asr street, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 mhdolatian@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iranian Married Have Vaginal delivery The baby's weight should be between 2500 and 4000 gr Have moderate to sever postpartum pain Speak Persian Nulliparous Aged 18 - 35 years 18 years 35 years Female Complication after delivery such as vaginal bleeding Fever Taking another painkillers more than one dose per day blood pressure more than 140/90 R10.2 Pelvic and perineal pain Treatment - Drugs Placebo Intervention group: 2 hours after delivery, every 8 hours for 24 hours, a Valerian capsule containing 500 mg of its powder is given, and one hour after each intervention, if the pain does not improve, a 250 mg Mefenamic acid capsule is given. This capsule will produce at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Control group: 2 hours after delivery, every 8 hours for 24 hours, a placebo capsule containing 500 mg of starch powder is given, and one hour after each intervention, if the pain does not improve, a 250 mg Mefenamic acid capsule is given. This capsule will produce at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Severity of postpartum pain. Timepoint: Before the intervention and one hour after. Method of measurement: MacGill Pain Ruler. Side effects of the drug. Timepoint: after intervention. Method of measurement: side effect questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-03-07 Ethics Committee of Pharmacy, Nursing and Midwifery Faculties of Shahid Beheshti University of Medic No.1,Ethics Committee of Pharmacy, Nursing and Midwifery Faculties of Shahid Beheshti University of Medical Sciences,In front of Shahid Rajaei Heart Hospital,Hashemi Rafsanjani Blvd,Valiasr Ave. Tehran Tehran Tehran Iran (Islamic Republic of)