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IRCT20151227025726N32 IRCT 2023-05-01 Shahid Beheshti University of Medical Sciences Effects of Melatonin in Patients with Pulmonary Sarcoidosis Evaluation of the Effects of Melatonin in Improvement of Chronic Fatigue Syndrome and Quality of life in Patients with Pulmonary Sarcoidosis 2023-05-20 anticipated 100 Complete https://irct.ir/trial/69386 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is used in this study. Twenty-five blocks including 4 patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, 2 patients will be assigned to melatonin group and 2 patients will be assigned to control group, Blinding description: In this study, the main investigator is unaware of the study groups. The randomization form will be provided to the nurse after evaluation of the inclusion and exclusion criteria and administration will be done based on the form. The investigator is blind to the study groups. 3 Pulmonary Sarcoidosis. Intervention 1: Intervention group: Patients receive 3 mg of melatonin one hour before bedtime for three months. Intervention 2: Control group: Patients do not use melatonin before going to bed. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making patients unidentifiable. When: Six months after publishing the results. To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers through Email (fzh.dastan@gmail.com) Comments:
public Sahar Yousefian
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2227 saahar26@yahoo.com Shahid Beheshti University of Medical Sciences scientific Farzaneh Dastan
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 2712 2227 f_dastan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People over 18 years old People with pulmonary sarcoidosis and concomitant sleep disorder (PSQI ≥ 3) Have signed the consent to participate in the study 18 years no limit Both Pregnancy Breastfeeding History of central nervous system disease (stroke, epilepsy, tumor, history of neurological manipulation) Taking any sedative-hypnotic drugs (antihistamines, benzodiazepines) Taking stimulant drugs Allergy to melatonin or formulation components Having parasomnias Shift work sleep disorder Taking fluvoxamine D86.0 Sarcoidosis of lung Treatment - Drugs Other Intervention group: Patients receive 3 mg of melatonin one hour before bedtime for three months. Control group: Patients do not use melatonin before going to bed. The amount of sleepiness during the day. Timepoint: At the start and end of the study. Method of measurement: ESS criteria. Fatigue state. Timepoint: At the start and end of the study. Method of measurement: FAS and PROMIS criteria. Quality of Life. Timepoint: At the start and end of the study. Method of measurement: SF-12 criteria. Pulmonary function of patients. Timepoint: At the start and end of the study. Method of measurement: Spirometry. Shahid Beheshti University of Medical Sciences Approved 2023-01-10 Ethics Committe of Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)