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IRCT20180424039397N1 IRCT 2018-09-19 Iran University of Medical Sciences The impact of cucurbita pepo oil on insomnia Comparing the efficacy of the traditional medicine product of cucurbita pepo oil and placebo topically administered in patients with insomnia 2018-07-23 anticipated 74 Complete https://irct.ir/trial/31300 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The eligible individuals will be allocated to either the intervention or control group using the table of random numbers, Blinding description: At first, the objectives of the study will be explained to the participants. the hospitalized patients will receive the drug or placebo by a nurse. however, neither the participants nor the nurses will be aware of the given medication. 2 Primary insomnia. Intervention 1: Intervention group (cucurbita pepo oil): Members of the intervention group will receive two drops of cucurbita pepo oil in the nose one hour before bedtime for two weeks. Intervention 2: Control group (liquid paraffin): Members of the control group will receive two drops of liquid paraffin in the nose one hour before bedtime for two weeks. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data Set The file will be provided in axcel file format. When: From the time the article extracted from the project is published for 6 months To whom: to researchers Conditions: for research and scientific purposes Where to obtain: Personal correspondence via email to the article authors How to obtain: email correspondence Comments:
public Dr Elham Haghjoo
Hasanabad Square
Tehran Iran (Islamic Republic of) 1449614535 +98 21 5558 0388 E_HAGHJOO_56@YAHOO.COM Iran University of Medical Sciences scientific Dr Asieh Shojaei
Hasanabad Square
Tehran Iran (Islamic Republic of) 1449614535 +98 21 5558 0388 Shojaii.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age between 20 to 65 years Individuals with sleep difficulty despite observance of sleep health tips Those who have trouble starting sleep or those who are not satisfied with their sleep quality, or both. Patients who score 3 or greater for either of the first two items on the Insomnia Severity Index Patients whose total score of the first two items on the Insomnia Severity Index is 4 or greater, and whose main complaint is insomnia. 20 years 65 years Both Having associated physical diseases such as cancer that cause insomnia Having mental diseases such as psychosis Having a history of drug abuse Having neurological diseases such as the Parkinson's disease, Alzheimer's disease, and epilepsy Pregnant and breast-feeding women History of allergy to medicinal herbs F51.01 Primary insomnia Treatment - Drugs Placebo Intervention group (cucurbita pepo oil): Members of the intervention group will receive two drops of cucurbita pepo oil in the nose one hour before bedtime for two weeks. Control group (liquid paraffin): Members of the control group will receive two drops of liquid paraffin in the nose one hour before bedtime for two weeks. Sleep quality. Timepoint: Before intervention, one week after the study onset, after intervention is finished. Method of measurement: Sleep log form. Subjective Quality of Sleep. Timepoint: Before intervention, one week after the study onset, after the intervention is finished. Method of measurement: Sleep log form. Sleep efficiency. Timepoint: Before intervention, one week after the study onset, after the intervention is finished. Method of measurement: Sleep log form. Delayed sleep initiation. Timepoint: Before intervention, one week after the study onset, after the intervention is finished. Method of measurement: Sleep log form. Insomnia severity. Timepoint: Before intervention, one week after the study onset, after the intervention is finished. Method of measurement: Insomnia Severity Index. Iran University of Medical Sciences Approved 2018-03-13 Ethics Committee of Iran University of Medical Sciences Hemmat Expressway Tehran Tehran Iran (Islamic Republic of)