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IRCT20200128046288N1 IRCT 2020-04-15 Ahvaz University of Medical Sciences Hypnotic effect of Lactuca sativa seed in patients with insomnia Hypnotic effect of Lactuca sativa seed in patients with insomnia: a randomized double-blind clinical trial 2020-03-18 anticipated 60 Complete https://irct.ir/trial/45451 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the permuted block randomization will be used with quadruple blocks. blocks will be produced by using the online site (www.sealedenvelope.com), Blinding description: Unique codes, which is generated by the software, will be used on the drug and placebo boxes. By entering each individual into the study based on the produced sequence, the drug or placebo box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups. 2-3 Primary insomnia. Intervention 1: Intervention group: They will receive 15 ml of lettuce seed syrup that will be made by the researchers of the present Project, every night for four weeks. Each 15 ml of syrup contains 100 mg total phenols as gallic acid equivalents. The intervention group will receive their routine insomnia medications during the study. Intervention 2: Control group: They will receive placebo syrup every night for four weeks.The control group will receive their routine insomnia medications during the study. Yes - There is a plan to make this available What will be shared: Only part of the data will be shared When: The access time is up to 6 months after the results are published To whom: Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis. Conditions: Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis. Where to obtain: Applicants can email the responsible author to receive the requested data How to obtain: Applicants will have access to the data from the present study by emailing the responsible author for up to one month. Comments:
public Fereshteh Golfakhrabadi
Ahvaz Jundishapur University of Medical Sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8378 golfakhrabadi@yahoo.com Ahvaz University of Medical Sciences scientific Fereshteh golfakhrabadi
Ahvaz Jundishapur University of Medical Sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8378 golfakhrabadi@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) People 20 to 50 years History of Primary Insomnia Disorder (People with sleep disorders have difficulty starting and maintaining sleep and feel tired and restless after waking up. Their daily functioning decrease and they are constantly thinking of having a restful sleep. The women in the study had a negative pregnancy test and had appropriate prevention methods during the study. No history of asthma and heart disease (heart block and heart failure) Patients should not use analgesic drugs regularly for any reason 20 years 50 years Both A history of secondary insomnia disorder, such as insomnia from medication use, or sleep disorder related to another mental disorder Pregnancy and Lactation History of heart, kidney or liver disease History of neurological and neurological diseases History of diabetes F51.01 Primary insomnia Treatment - Drugs Treatment - Drugs Intervention group: They will receive 15 ml of lettuce seed syrup that will be made by the researchers of the present Project, every night for four weeks. Each 15 ml of syrup contains 100 mg total phenols as gallic acid equivalents. The intervention group will receive their routine insomnia medications during the study. Control group: They will receive placebo syrup every night for four weeks.The control group will receive their routine insomnia medications during the study. Subjective sleep quality. Timepoint: In addition to the first visit, patients will be visit at the end of the fourth week after receiving the medication. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Sleep Time. Timepoint: In addition to the first visit, patients will be visit at the end of the fourth week after receiving the medication. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Sleep Duration. Timepoint: In addition to the first visit, patients will be visit at the end of the fourth week after receiving the medication. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Daytime dysfunction. Timepoint: In addition to the first visit, patients will be visit at the end of the fourth week after receiving the medication. Method of measurement: Pittsburgh Sleep Quality Questionnaire. The rate of drug side effects. Timepoint: During drug use. Method of measurement: Patient Report. Ahvaz University of Medical Sciences Approved 2019-07-19 Ethics committee of Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences,, Golestan street Ahvaz Khouzestan Iran (Islamic Republic of)