]>
IRCT20191002044948N1 IRCT 2020-02-04 Shahid Beheshti University of Medical Sciences Effect of hydro-alcoholic extract of Capsella bursa Pastoris on postpartum pain Effect of hydro-alcoholic extract of Capsella bursa Pastoris on postpartum pain 2019-07-06 anticipated 100 Complete https://irct.ir/trial/42813 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization perform by an independent trial center. If a patient fulfill the inclusion criteria and has signs informed consent, the researcher contacts the trial center. A quadratic permutation block method used. Subjects in blocks 1, 3 and 5 entered into the control group and subjects in blocks 2, 4 and 6 entered into the intervention group and simple randomized table used to select blocks. To assign patients to study groups the random assignment sheet will be used by trained personnel, Blinding description: The placebo is similar to the drug regarding shape of container, color, and volume and the researcher and patient will not aware of the type of extract or placebo. The outcome assessor do not know the types of the patient's intervention and only has the patient's specific code. In addition, statistician will not aware of the study groups. 3 postpartum pain. Intervention 1: The intervention group received mefenamic acid capsule 250 mg, every 6 hours for a maximum of 4 doses for 24 hours plus 10 sublingual drops of hydroalcoholic extract of Capsella bursa Pastoris containing 500 mg of the extract. Intervention 2: Control group received mefenamic acid capsule 250 mg, every 6 hours for a maximum of 4 doses for 24 hours plus 10 drops placebo (distilled water) sublingually. Yes - There is a plan to make this available What will be shared: All potential data can be shared after unidentifiable people When: 6 months after printing the results To whom: researchers Conditions: Correspondence Where to obtain: Mailing address to researcher How to obtain: 1 month Comments:
public Dr. Nour sadat Kariman
Vice-Chancellor for Research, Midwifery Nursing and Midwifery, Third floor, Vice chancellor for research, Shahid Rajaee Heart Hospital
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2516 n_kariman@yahoo.com Shahid Beheshti University of Medical Sciences scientific Noursadat Kariman
Vice chancellor for research, Third floor, Vice chancellor for research, Nursing and Midwifery Faculty, Valiasr Ave.
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8820 2516 n_kariman@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Normal Delivery The gestational age is 37-42 weeks Live single baby with cephalic presentation The fetal weight is 2500-4000 Moderate or severe pain based on Pain Ruler no limit no limit Female Any problems that require emergency action such as maternal bleeding Severe bleeding Difficult and prolonged childbirth and use of tools analgesics for childbirth Drug addiction or psychotropic drugs Systemic disease Perineal ruptures grade 3 and 4 G89.18 Other acute postprocedural pain Treatment - Drugs Placebo The intervention group received mefenamic acid capsule 250 mg, every 6 hours for a maximum of 4 doses for 24 hours plus 10 sublingual drops of hydroalcoholic extract of Capsella bursa Pastoris containing 500 mg of the extract. Control group received mefenamic acid capsule 250 mg, every 6 hours for a maximum of 4 doses for 24 hours plus 10 drops placebo (distilled water) sublingually. Severity of pain. Timepoint: Every 1 hour up to six hours after intervention and then every 6 hours up to 24 hours after intervention. Method of measurement: Pain Ruler. Duration of pain. Timepoint: One hour after taking the drug. Method of measurement: In hours and minutes. Shahid Beheshti University of Medical Sciences Approved 2017-07-01 Ethics committee of Shahid Beheshti University of Medical Sciences University Square.,Nilufar Ave.,Maryam Street., Damqan Town.,Plaque21 Damqan Semnan Iran (Islamic Republic of)