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IRCT20110906007494N37 IRCT 2021-06-22 Mazandaran University of Medical Sciences The Effect of Noma syrup on insomnia in hemodialysis patient Comparison of Effect of Noma Syrup (Lactuca sativa leaf extract) with Clonazepam Tablet on Insomnia Severity in Hemodialysis Patients 2021-07-01 anticipated 102 Complete https://irct.ir/trial/56322 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible individuals are randomly assigned to two groups of 51 intervention and control using random numbers provided by computer software and Permuted Block Randomization by a statistical consultant. 25 blocks of 4 and one block of 2 so that in blocks of 4, two people from the intervention group and two people from the control group and in the block of two, one person from the intervention group and one person from the control group . Therefore, 102 envelopes are designed and the letter A (intervention group) and the letter B (control group) are embedded in it based on the information obtained from the computer program. Envelopes are numbered from one to 102. Respectively, the first patient who is admitted to the ward and has the inclusion criteria enters the study after obtaining informed written consent and sampling continues until patient number 102. N/A Insomnia severity. Intervention 1: Intervention group: Noma syrup containing 240 ml of processed lettuce leaf extract is consumed 20 ml every night, half an hour before going to bed for two weeks. Intervention 2: Control group: Clonazepam tablets will be given half a mg each night, half an hour before bedtime, for two weeks to subjects in the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more informatio
public Masoumeh Bagheri Nesami
Reseach Assistant of Mazandaran University of Medical sciences
Sari Iran (Islamic Republic of) 4815733971 +98 11 3379 5508 arashazad1986@gmail.com Mazandaran University of Medical Sciences scientific Masoumeh Bagheri Nesami
Mazandaran University of Medical Sciences,three way Joibar,highway basij,imam square,Sari,Mazandaran
Sari Iran (Islamic Republic of) 4816715793 +98 11 3379 5508 Anna3043@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) People 18 years and older with insomnia hemodialysis two or three times a week Iranian nationality mental alertness and ability to answer questions lack of delirium (Delirium Screening Nursing Scale (NE-DESC)) Lack Existence of cognitive problems (examination by MMSE test) no history of stroke Lack of incurable diseases such as cancer Absence of severe hearing and vision problems No substance abuse 18 years no limit Both Patients taking anti-anxiety or hypnotic drugs due to neuropsychiatric disorders Patients using combination therapies such as acupuncture, herbal remedies, hypnosis or yoga The patient's unwillingness to continue participating in the study Exacerbation of sleep disorder Delirium incidence Allergic reaction or death of the patient G47.00 Insomnia, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Noma syrup containing 240 ml of processed lettuce leaf extract is consumed 20 ml every night, half an hour before going to bed for two weeks. Control group: Clonazepam tablets will be given half a mg each night, half an hour before bedtime, for two weeks to subjects in the control group. Insomnia Severity. Timepoint: Before the intervention and after the intervention. Method of measurement: Insomnia Intensity Scale. Mazandaran University of Medical Sciences Approved 2021-06-13 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran. Sari Mazandaran Iran (Islamic Republic of)