]>
IRCT20140525017827N11 IRCT 2021-08-14 Shiraz University of Medical Sciences The comparison of the effect of bitter orange and ondansetron on treatment of nausea and vomiting of pregnancy The comparison of the effect of bitter orange and ondansetron on treatment of nausea and vomiting in pregnant women between weeks 6 till 20 of pregnancy 2021-08-23 anticipated 80 Complete https://irct.ir/trial/57819 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The treatment allocation list is already designed on Block Balanced Randomization Method by software ( https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html) (A), 2 (B), 3 (B), 4 (B), 5 (A),……. Any eligible patient will be given a 1 to 80 code after obtaining informed consent in order to visit the clinic and based on above block, they receive A or B drug, Blinding description: Ondansetron and bitter orange peel have been administered in the similar bottles, so patients and researchers were unable to detect which one was Ondansetron or bitter orange peel. Our nurse colleague in this study in hospital delivered formulations to the participants of the study according to Block Balanced Randomization Method by software. 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 Nausea & vomiting in pregnancy. Intervention 1: Intervention group: Treatment of one group with bitter orange. Intervention 2: Intervention group: The other group with ondansetron. Yes - There is a plan to make this available What will be shared: Statistical Results When: 6 month after the project completion To whom: By obtaining a license from the ethics committee and for scientific and research use in coordination with the main researchers Conditions: The data is for use in this design only. If necessary, after obtaining the necessary permits from the ethics committee Where to obtain: To researchers responsible for responding to this plan How to obtain: Written request Coordinated by the ethics committee 2 months Comments:
public Farrokh khani
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 Farrokhkhani1368@gmail.com Shiraz University of Medical Sciences scientific Nasrin asadi
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 nasadi2012@yahoo.ca Shiraz University of Medical Sciences Iran (Islamic Republic of) gestational age between 6-20 weeks of pregnancy (according to a reliable LMP and ultrasound confirmation of the first trimester) Having mild to moderate nausea and vomiting without a need of hospitalization Singleton pregnancy with a live normal fetus Not having any known gastrointestinal disorder Without a history of smoking or drug use Lack of a known mental illness such as severe anxiety and depression Not having any known allergy or hypersensitivity to herbal medications no limit no limit Female Severe nausea and vomiting needing hospitalization No acceptance for herbal medicine Having any other symptoms showing pathologic problems such as diarrhea Having any known gastrointestinal or any other systemic disorder or any drug use except common supplementation (folic acid) O21.9 Vomiting of pregnancy, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Treatment of one group with bitter orange Intervention group: The other group with ondansetron Intensity of nausea and vomiting. Timepoint: Before start and two weeks later of treatment. Method of measurement: Visual analog scale. Quality of life score. Timepoint: Before start and two weeks later of treatment. Method of measurement: Short Form 36 Health Survey (SF-36). Shiraz University of Medical Sciences Approved 2021-06-27 Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz Shiraz Fars Iran (Islamic Republic of)