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IRCT20140525017827N7 IRCT 2019-10-22 Shiraz University of Medical Sciences The effect of lettuce seed oil on insomnia in pregnancy Effect of lettuce seed oil extract on treatment of insomnia in pregnant women and study of urinary melatonin before and after taking 2019-11-22 anticipated 90 Complete https://irct.ir/trial/42854 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use similar bottles, Blinding description: lettuce seed oil and placebo have been administered in the similar bottles, so patients and researchers were unable to detect which one was Pentoxifiylline or placebo. Our nurse colleague in this study in Hafez hospital delivered formulations to the participants of the study according to the randomized block table. 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. N/A Nonorganic insomnia. Intervention 1: Intervention group: lettuce seed oil twice daily for 14 days. Intervention 2: Control group: Placebo twice a day for 14 days made by the Faculty of Pharmacy of Shiraz university of medical sciences. Yes - There is a plan to make this available What will be shared: IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient When: IPD: 2019 Ethic form: 2019 To whom: IPD: Researcher & Patient Ethic form: Patient Conditions: IPD: Ethic form: Awareness of test results Where to obtain: IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences How to obtain: IPD: Vice chancellery Ethic form: Vice chancellery Comments:
public Omolbanin Hassani
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3233 2365 banin.hassani5349@gmail.com Shiraz University of Medical Sciences scientific Nasrin Asadi
Maternal- Fetal Medicine (Perinatology) research center, Hafez Hospital, Chamran Ave., Shiraz
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 nasadi2012@yahoo.ca Shiraz University of Medical Sciences Iran (Islamic Republic of) Women with aged between 20-45 years Gestational aged between 23-26 weeks with Pittsburgh sleep quality index score more than 5 20 years 45 years Female Patient must not have been taking hypnotic drug Interventions and outcomeshigh risk pregnancy (Multiple pregnancy, gestational diabetes mellitus, hypertension, preeclampsia, .....) patients must not have suffered from insomnia before pregnancy patients must not have been treated by LS oil within the preceding year patient must not have been taking hypnotic drug F51.0 maternal disorders predominantly related to pregnancy Treatment - Drugs Placebo Intervention group: lettuce seed oil twice daily for 14 days Control group: Placebo twice a day for 14 days made by the Faculty of Pharmacy of Shiraz university of medical sciences. Measurment of urine Melatonine. Timepoint: Before and after treatment. Method of measurement: ELISA. Shiraz University of Medical Sciences Approved 2019-05-20 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz Shiraz Fars Iran (Islamic Republic of)