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IRCT20241105063604N1 IRCT 2024-11-15 Shiraz University of Medical Sciences Investigating the effect of quince sauce in preventing nausea and vomiting of pregnancy Investigating the effect of quince sauce in preventing nausea and vomiting of pregnancy 2024-11-21 anticipated 80 Complete https://irct.ir/trial/79982 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups (A and B). The random allocation method of permutation blocks will be performed using Random Allocation software. First, six different blocks will be created (ABBA, BABA, ABAB, BBAA, AABB and BABA) and one of these blocks will be randomly selected and, according to the order mentioned in the selected block, the patients will be divided into one of two groups (intervention) A or (control) B. Then, randomization will be performed for other patients as well. The intervention group (A) will include pregnant women who will be treated with quince sauce (made by the Faculty of Pharmacy, Shiraz University of Medical Sciences) for 7 days, 10 mg three times a day. The control group (B) will be prescribed the second drug andasterone and vitamin B6 for 1 tablet every 12 hours. 0 (exploratory trials) Nausea and vomiting of pregnancy. Intervention 1: Intervention group: Pregnant women treated with quince sauce will receive 10 mg three times a day for 7 days. Intervention 2: Control group: Women treated with ondansetron and vitamin B6 for 1 tablet every 12 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is The publication of any matter related to the research project must be coordinated with the Vice President for Research of Shiraz University of Medical Sciences.
public Marzieh Khezri
Zand Street - Faculty of Medicine
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3230 5884 dr.marziehkhezri@gmail.com Shiraz University of Medical Sciences scientific Marzieh Khezri
Zand Street - Faculty of Medicine
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3230 5884 dr.marziehkhezri@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Being in a singleton, normal pregnancy where the gestational age is 6 to 22 weeks based on the first day of the last regular menstrual period or first trimester ultrasound. Absence of molar pregnancy, twin pregnancy, and signs of threatened miscarriage Absence of thyroid dysfunction and any known gastrointestinal disease No known illness that causes nausea and vomiting Mild to moderate nausea and vomiting Not taking any herbal or chemical anti-nausea or anti-emetic medication within the past twenty-four hours. No smoking 18 years 35 years Female Severe nausea Failure to take two or more courses of medication or concurrent use of other anti-nausea medications, such as herbal or chemical anti-nausea medications Threatened miscarriage Allergy to quince sauce and andasterone and vitamin B6 O21.9 Vomiting of pregnancy, unspecified Treatment - Other Treatment - Drugs Intervention group: Pregnant women treated with quince sauce will receive 10 mg three times a day for 7 days. Control group: Women treated with ondansetron and vitamin B6 for 1 tablet every 12 hours Nausea and vomiting of pregnancy. Timepoint: Before starting treatment and 7 days after starting treatment. Method of measurement: The second standard Rhodes Nausea and Vomiting Questionnaire was developed by Rhodes and McDaniel in 1999 and consists of 8 factors: the number, severity, and amount of vomiting, the number, duration, and severity of nausea, and the number and severity of retching, which are asked during the past 12 hours. Shiraz University of Medical Sciences Approved 2024-08-22 Ethics Committee of Shiraz University of Medical Sciences Shiraz, Zand Street, Central Building of University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)