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IRCT20210303050564N1 IRCT 2021-04-14 Shahid Beheshti University of Medical Sciences Comparing Ondansetron and Ginger for the treatment of nausea and vomiting in pregnancy Comparing Ondansetron and Ginger for the treatment of nausea and vomiting in pregnancy on pregnant women attending prenatal clinic 2021-04-09 anticipated 150 Complete https://irct.ir/trial/54858 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random, Blinding description: Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. It should be noted that based on the three-sided blindness of the research, the researcher, research units and statisticians will not know any of the drugs used. 3 Nausea and vomiting in pregnancy. Intervention 1: Intervention group: ondansetron Ondansetron powder is prepared from a pharmaceutical company. Then, in Tehran Shahid Beheshti School of Pharmacy, monochromatic capsules will be filled and coded with 8 mg of ondansetron powder. Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. They will not know the type of medicine used. The method of taking the drug is one capsule every 12 hours for up to 4 days. People will record the severity of their nausea and vomiting every day based on the questionnaire. Intervention 2: Intervention group: ginger Ginger root powder is prepared from a reputable center. Then, in Tehran Shahid Beheshti School of Pharmacy, monochromatic capsules will be filled and coded with 500 mg of ginger root powder. Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. They will not know the type of medicine used. The method of taking the drug is one capsule every 12 hours for up to 4 days. People will record the severity of their nausea and vomiting every day based on the questionnaire. Yes - There is a plan to make this available What will be shared: Total data When: 6 months after printing the results To whom: For academics Conditions: Academic use Where to obtain: marjan_akhavan2003@yahoo.com How to obtain: Up to one month after making the call Comments:
public Faraz Mojab
Vali Asr St. Niayesh Cross Section
Tehran Iran (Islamic Republic of) 14155-1817 +98 21 8820 9627 sfmojab@yahoo.com Shahid Beheshti University of Medical Sciences scientific Faraz Mojab
Vali Asr St, Niayesh Cross Section
Tehran Iran (Islamic Republic of) 14155-1817 +98 21 8820 9627 sfmojab@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Gestational age 6-16 weeks Mild to moderate nausea and vomiting Single pregnancy 18 years 45 years Female Known underlying disease Risk of pregnancy Take anticoagulants Known insensitivity to ginger and ondansetron O21.0 O21.0 Mild hyperemesis gravidarum Treatment - Drugs Treatment - Drugs Intervention group: ondansetron Ondansetron powder is prepared from a pharmaceutical company. Then, in Tehran Shahid Beheshti School of Pharmacy, monochromatic capsules will be filled and coded with 8 mg of ondansetron powder. Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. They will not know the type of medicine used. The method of taking the drug is one capsule every 12 hours for up to 4 days. People will record the severity of their nausea and vomiting every day based on the questionnaire. Intervention group: ginger Ginger root powder is prepared from a reputable center. Then, in Tehran Shahid Beheshti School of Pharmacy, monochromatic capsules will be filled and coded with 500 mg of ginger root powder. Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. They will not know the type of medicine used. The method of taking the drug is one capsule every 12 hours for up to 4 days. People will record the severity of their nausea and vomiting every day based on the questionnaire. The severity of nausea and vomiting. Timepoint: Measure the severity of nausea and vomiting at the beginning of the study and daily during treatment. Method of measurement: Rhodes Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2021-01-29 Ethics Committee of Shahid Beheshti University of Medical Sciences, Tehran Nyaiesh, Hashemi Rafsanjani Bulvar, Valiasr Ave Tehran Tehran Iran (Islamic Republic of)