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IRCT20170821035819N2 IRCT 2020-01-29 Tehran University of Medical Sciences Comparing safety and efficacy of melatonin, trazodone, and clonazepam on the sleep quality of patients with Parkinson's disease Comparing safety and efficacy of melatonin, trazodone, and clonazepam on the sleep quality of patients with Parkinson's disease in patients referring to the Neurology Clinic of Roozbeh Hospital 2019-06-22 anticipated 90 Complete https://irct.ir/trial/44879 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization Patients are divided into three treatment groups with 3 mg melatonin (A), 50 mg trazodone (B), and 1 mg clonazepam (C) using a simple random allocation method and a random number table. We referred "https://www.graphpad.com/quickcalcs/randomize2/" website for randomization, total sample size is 90 and were divided into three groups (A, B, C) each of them 30 patients. This is a randomized double-blind study. The drugs (Melatonin, Trazodone, and Clonazepam) are packaged in separate but similar packages and labeled A, B, and C on them. As a result, the patient is unaware of the type of drug in each package, and the analyst is also blinded. Method of administration: For the A group, 3 mg of Melatonin tablets are administered overnight (before bedtime). For the B group, 50 mg Trazodone is given overnight (before bedtime). For the C group, 1mg Clonazepom is given overnight (before bedtime), Blinding description: This is a double blind study. The drugs are divided into groups A, B and C by a third person and given to the researcher. The researcher, participant and evaluator are unaware of the drug, until all data are fully analyzed. 3 Sleep disorder of patients with Parkinson's disease. Intervention 1: Intervention group: Patients with Parkinson's disease who have sleep disorder, Take 3 mg Melatonin, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company). Intervention 2: Control group: Patients with Parkinson's disease who have sleep disorders, Take 50 mg Trazodone, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company). Intervention 3: Control group: Patients with Parkinson's disease who have sleep disorders, Take 1 mg Clonazepam, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company). Yes - There is a plan to make this available What will be shared: The Article will be publish in international journal and part of the data, such as information about the original outcome can shared without patients identification details. When: 2020 To whom: Published article will be available to everyone. Conditions: Data will be made available to research organizations and managers as needed. Where to obtain: Dr Vajiheh Aghamollaii How to obtain: Reason for request and affiliation person who requested data Comments:
public Vajiheh Aghamollaiy
Keshavarz Blvd.Rouzbeh Hospital, Tehran, Iran
Tehran Iran (Islamic Republic of) 1333715914 +98 21554191515 v-aghamollaii@sina.tums.ac.ir Tehran University of Medical Sciences scientific Vajiheh Aghamollaii
Kargar Sr
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 9151 vajiheh102@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with Parkinson's disease who have sleep disorder based on history. 50 years 80 years Both Dementia A history of drug sensitivity G20 Parkinson's disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients with Parkinson's disease who have sleep disorder, Take 3 mg Melatonin, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company) Control group: Patients with Parkinson's disease who have sleep disorders, Take 50 mg Trazodone, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company) Control group: Patients with Parkinson's disease who have sleep disorders, Take 1 mg Clonazepam, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company) Sleep quality. Timepoint: First time and After 1 month. Method of measurement: Pittsburgh sleep quality questionnaire. Daytime sleepiness. Timepoint: First time and After 1 month. Method of measurement: Epworth sleepiness score questionnaire. Sleep Disorder. Timepoint: First time and After 1 month. Method of measurement: REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). Tehran University of Medical Sciences Approved 2018-10-28 Ethics committee of Islamic Azad Tehran Medical Sciences University - Pharmacy and Pharmaceutical Br Doctor Shariati stereet, Qolhak Tehran Tehran Iran (Islamic Republic of) Approved 2018-10-28 Ethics committee of School of Medicine - Tehran University of Medical Sciences Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St. Tehran Tehran Iran (Islamic Republic of)