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IRCT20200214046492N1 IRCT 2020-04-01 Yasouj University of Medical Sciences Evaluation of the effect of mixed ethanolic extract (Black seed and Dill seeds) on pain and post partum hemorrage PPH Evaluation of the effect of mixed ethanolic extract (Black seed and Dill seeds) on some parameters of postpartum maternal physical health compared with mefnamic acid 2020-04-03 anticipated 62 Complete https://irct.ir/trial/46129 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Use 2 ethanol herbal in one capsule, Randomization description: The study units will be divided into groups A and B on the basis of random allocation by computer random generation. The appearance of the drug and placebo will be quite similar. The participants and the researcher are completely unaware of the drugs, but the pharmacist is aware (double-blinded), Blinding description: The patient and nurse do not know kind of medicine. All patient was taken the same shape medicine. 1-2 Postpartum hemorrhage and pain. Intervention 1: Intervention group A: The black seeds and dill seeds are each washed separately and after drying in the shade, the plant will be milled, and extracted with 70% ethanol for 48 hours by maceration technique. The hydroalcoholic solution is then separated by filter paper from the plant particles and the remaining ethanol is collected by a rotary machine. The residue of the extract is kept at 37 ° C for evaporation. Finally, the dried extract is stored at 20 ° C for testing in the clinical laboratory. The selective dose of the dried extract in the combined capsule in the present study was 500 mg of black seed and 400 mg of dill daily. It should be noted that the relevant dose has been selected after studying the previous articles, evaluating human safety and the opinion of the consultant professor. Intervention 2: Intervention group B: Mefenamic acid will be completely similar in appearance to group A and will be administered in the same manner. Mefenamic acid will be administered 250 mg every six hours during the first three days after delivery. Yes - There is a plan to make this available What will be shared: Information about main outcomes of the study When: Six months after publishing the results To whom: Researchers in universities and scientific and research centers Conditions: In order to improve the control of postpartum hemorrhage and pain, and subsequent researches, and with the permission of the authors Where to obtain: Department of Obstetrics and Gynecology of Yasuj university of medical sciences How to obtain: Sending the request in writing or by email to the authors Comments:
public Elaheh Foroutanifard
Emam Sajad Hospital, Saheli Str
Yasuj Iran (Islamic Republic of) 75919-94799 +98 74 3322 0116 vestal2475@yahoo.com Yasouj University of Medical Sciences scientific Fatemeh Bazarganipoor
Emam Sajad Hospital, Saheli Str
Yasuj Iran (Islamic Republic of) 75919-94799 +98 74 3322 0162 vestal2475@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Gestation age 38-42 week Singletone pregnancy NVD Mother age 15-44 iranian spontaneous placental remove no previous surgery no spinal or opium HB>8 no ROM >12 no opium addiction no sensetive to herbal no percipitate labor or prolonge labor BMI 18/5-29/5 Fetal weight 2500-4000 no disease in mother no operative vaginal delivery no 3,4 degree laceration no use warfarin,banzodiazepin,ASA,Alcohol,heparin 15 years 44 years Female no breast feeding no cooprative patient use another herbal no sensetive to herbal severe dissease in mother and neonate O72.1 Other immediate postpartum hemorrhage Treatment - Drugs Treatment - Drugs Intervention group A: The black seeds and dill seeds are each washed separately and after drying in the shade, the plant will be milled, and extracted with 70% ethanol for 48 hours by maceration technique. The hydroalcoholic solution is then separated by filter paper from the plant particles and the remaining ethanol is collected by a rotary machine. The residue of the extract is kept at 37 ° C for evaporation. Finally, the dried extract is stored at 20 ° C for testing in the clinical laboratory. The selective dose of the dried extract in the combined capsule in the present study was 500 mg of black seed and 400 mg of dill daily. It should be noted that the relevant dose has been selected after studying the previous articles, evaluating human safety and the opinion of the consultant professor. Intervention group B: Mefenamic acid will be completely similar in appearance to group A and will be administered in the same manner. Mefenamic acid will be administered 250 mg every six hours during the first three days after delivery. Postpartum hemorrhage. Timepoint: Before study then first hour till 6hrs then till 3days. Method of measurement: Iranian GYN and OB protocol. Pain. Timepoint: Before study then first hour till 6hrs then till 3days. Method of measurement: Visual Analogue Scale Score. Breast feeding. Timepoint: Three days in the time of intervention then 2 weeks later. Method of measurement: Urination and defication of neonate. Liver function. Timepoint: After intervention. Method of measurement: Blood test. Complete Blood Count. Timepoint: After intervention. Method of measurement: Blood test. Renal function. Timepoint: After intervention. Method of measurement: Blood test. Sodium, Potassium. Timepoint: After intervention. Method of measurement: Blood test. Yasouj University of Medical Sciences Approved 2020-02-13 Ethics committee of Yasuj University of Medical Sciences Faculty of medicine, Medical campus, Next to Imam Sajjad Hospital, Shahid Dr. Ghorban Ali Jalil Ave Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)