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IRCT20170513033941N29 IRCT 2018-01-23 Kashan University of Medical Sciences Effect of melatonin supplementation in treatment of patients with Parkinson's disease Clinical trial of the effect of melatonin supplementation compared with the placebo on clinical status, metabolic profiles and gene expression related to inflammation, insulin and lipid in patients with Parkinson's disease 2018-01-02 anticipated 60 Complete https://irct.ir/trial/28019 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. 2 Parkinson's disease. Intervention 1: Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients with Parkinson' disease. Individuals aged 50 to 90 years. 50 years 90 years Both Exclusion criteria: Unwillingness to cooperate G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks orally. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA test. UPDRS. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Physical Examination by Neurologist. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of TGF-β gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of PPAR-γ gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of LDL-R gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. PSQI. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questioner. BAI. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questioner. BDI. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questioner. Kashan University of Medical Sciences Approved 2018-01-01 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)