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IRCT20230221057481N1 IRCT 2023-02-24 Gonabad University of Medical Sciences The effect of rice bran intake on the severity of nausea and vomiting during pregnancy The effect of receiving rice bran on the severity of nausea and vomiting during pregnancy in women referred to comprehensive health service centers in Gonabad city - 2023 2023-04-04 anticipated 72 Complete https://irct.ir/trial/68769 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign the samples to each of the 2 intervention and control groups, blocks of 4 variables are used. In this way, first, 6 possible states of blocks of 4 are listed and a number from 1 to 6 is assigned to each block. Then a number between 1 and 6 is randomly selected and then people are assigned to the test (A) and control (B) groups based on the block corresponding to the selected number, Blinding description: Rice bran and white flour without fiber (placebo) are packed by the researcher in identical envelopes in terms of shape and size and coded with A and B codes; And the study will be blinded to the participants. N/A Nausea and vomiting of pregnancy. Intervention 1: Intervention group: For a week, every day, 2 times a day, they consume a 10 gram package of rice bran before lunch and dinner or with yogurt. Intervention 2: Control group: For a week, every day, twice a day, they consume a 10 gram package of white flour before lunch and dinner or with yogurt. Yes - There is a plan to make this available What will be shared: The participants are coded to increase access to them and their information, but at the time of publication, only the main result is published and the information of the participants is not published in any way. When: 6 months after the results are published To whom: Access is open to the public Conditions: If people have a request, without mentioning the coding of the information confidentially, without the personal information of the people, only the main and side results will be provided to the requester. Where to obtain: E-mail How to obtain: First, the applicant sends a message to the e-mail and explains the reason for using the data, and within a week, information with conditions and restrictions will be sent to the applicant. Comments:
public Fereshteh Haghighat Khah
On the side of Asian Road, Gonabad University of Medical Sciences
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 6975 frshthhqyqt4@gmail.com Gonabad University of Medical Sciences scientific Fereshteh Haghighat Khah
On the side of Asian Road, Gonabad University of Medical Sciences
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 6975 frshthhqyqt4@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in research Ability to read and write Age 18-35 Gestational age below 20 weeks based on the first day of the last menstrual period or ultrasound Desired pregnancy Single fetus, alive and natural Not using assisted reproductive methods to get pregnant No drug use Not suffering from chronic diseases and psychiatric disorders based on the mother's statements Not having a high-risk pregnancy Absence of serious and adverse events in the last 3 months Having mild or moderate nausea and vomiting of pregnancy based on the Rhodes standard criteria Not using chemical drugs or complementary medicine to control and treat nausea and vomiting of pregnancy from 3 days before the start of the study Insensitivity to white rice, brown rice and rice bran based on the person's statements 18 years 35 years Female Unwillingness to continue cooperation Occurrence of medical and midwifery problems The occurrence of severe and adverse events Severe nausea and vomiting based on the Rhodes questionnaire or nausea and vomiting with a cause other than pregnancy based on the diagnosis of a gynecologist Use of chemical drugs or complementary medicine to control and treat nausea and vomiting of pregnancy during the study period Allergy to rice bran used in the study Not using rice bran correctly or not using it for more than one day Failure to complete questionnaires or incomplete completion Treatment - Drugs Placebo Intervention group: For a week, every day, 2 times a day, they consume a 10 gram package of rice bran before lunch and dinner or with yogurt. Control group: For a week, every day, twice a day, they consume a 10 gram package of white flour before lunch and dinner or with yogurt. Severity of nausea and vomiting of pregnancy. Timepoint: Before starting the intervention and during the intervention for one week. Method of measurement: Rhodes Standard Questionnaire. Gonabad University of Medical Sciences Approved 2023-02-21 Ethics Committee of Gonabad University of Medical Sciences On the side of Asian Road, Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)