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IRCT20200224046607N1 IRCT 2020-03-29 Mashhad University of Medical Sciences "Red Onion in Gestational diabetes mellitus" The Effect of Oral Capsule of hydro-alcoholic Extract of Red Onion (Allium cepa) on Blood Glucose in Women with Gestational diabetes mellitus under Diet Therapy 2020-04-20 anticipated 82 Complete https://irct.ir/trial/46143 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling was done using available sampling and random allocation through binary blocks created by random Allocation Software, using random number table www.randomization.com in two groups (intervention and control).In fact, randomization is performed using binary blocks AB(1) and BA(2), so that A is the intervention group and B is the placebo group. The method of concealment would be to provide sealed envelopes, Blinding description: In order to blind the capsule of red onion extract and placebo, the researcher is provided with similar shapes and cans. Each box contains a code that the pharmacy consulting professor is aware of. Individuals with inclusion criteria are grouped according to the codes using a random number table. Therefore, by the end of the study, the researcher and the statistical analyst will not be aware of the codes for the red onion and placebo extract capsules. 3 Gestational Diabetes Mellitus. Intervention 1: Intervention group: Take the red onion extract capsule twice daily and in a 500 mg capsule half an hour after breakfast and lunch, with a 6 to 7 hour interval between meals and routine care including routine gestational diabetes training For 4 weeks. Intervention 2: Control group: Take Avesil containing placebo (microcrystalline cellulose) capsules two times a day, and a 500-mg capsule half an hour after breakfast and lunch, with a 6 to 7-hour interval between meals and routine care including diet training The usual diet will get gestational diabetes for 4 weeks. Yes - There is a plan to make this available What will be shared: Documents are shared after they are unrecognizable. When: 8 months after recording the results To whom: All researchers Conditions: All mothers with gestational diabetes and midwifery staff Where to obtain: Email to address salajeghehtf971@mums.ac.ir How to obtain: Initially, an e-mail will be sent to the library of Mashhad School of Nursing and Midwifery, if not answered for up to one week. Comments:
public Farzaneh salajegheh
School of Nursing and Midwifery, Ibn Sina Street, mashhad university of medical sciences, iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 salajeghehtf971@mums.ac.ir Mashhad University of Medical Sciences scientific Raheleh Babazadeh
School of Nursing and Midwifery, Ibn Sina Street, mashhad university of medical sciences, iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 BabazadehR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iranian nationality and resident in Mashhad Has minimum literacy skills Written consent to participate in the study Phone number for urgent contact with yourself or family members Pregnant mother age between 18-35 years Single pregnancy Gestational age 30-24 weeks Gestational diabetes is confirmed by tests and a doctor Fasting blood glucose test and two hours postprandial (to confirm treatment of gestational diabetes with post-OGTT impairment) fasting blood glucose below 93 mg / dl and two hours postprandial blood glucose below 120 mg / dl and confirmation of gestational diabetes control With a diet by a gynecologist Fasting serum glucose levels below 92mg / dl at first pregnancy visit Normal outcome of fetal malformation screening tests and fetal anomaly ultrasound 18 years 35 years Female Addiction to psychotropic substances, stimulants, alcohol, tobacco and opioids Having a medical condition Having midwifery problems Being a psychiatrist in the last 6 months and taking psychotropic drugs Allergy to onions or Lilias family members Preventive Speech and Behavioral Disorders Communication with Researcher O24.4 Diabetes mellitus arising in pregnancy Treatment - Drugs Treatment - Drugs Intervention group: Take the red onion extract capsule twice daily and in a 500 mg capsule half an hour after breakfast and lunch, with a 6 to 7 hour interval between meals and routine care including routine gestational diabetes training For 4 weeks. Control group: Take Avesil containing placebo (microcrystalline cellulose) capsules two times a day, and a 500-mg capsule half an hour after breakfast and lunch, with a 6 to 7-hour interval between meals and routine care including diet training The usual diet will get gestational diabetes for 4 weeks. Fasting blood glucose. Timepoint: At baseline, 2 weeks and 4 weeks after intervention. Method of measurement: Intravenous Blood Test. Blood glucose two hours after meals. Timepoint: At baseline, 2 weeks and 4 weeks after intervention. Method of measurement: Intravenous Blood Test. Mashhad University of Medical Sciences Approved 2020-02-18 Ethics committee of Mashhad University of Medical Sciences-School of Nursing and Midwifery School of Nursing and Midwifery, Ibn Sina Street, mashhad university of medical sciences, iran Mashhad Razavi Khorasan Iran (Islamic Republic of)