]>
IRCT20210618051612N1 IRCT 2021-07-13 Tehran University of Medical Sciences The effect of nicotine on Parkinson's disease. The effect of nicotine rich diet with / without redistribution of dietary protein on motor indices in patients with Parkinson's disease 2021-08-23 anticipated 45 Complete https://irct.ir/trial/56993 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use block randomization. The blockage is usually used to balance the number of samples allocated to each of the studied groups. All blocks are the same size. Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed. 3 Parkinson's disease. Intervention 1: Intervention group: The duration of the intervention is 12 weeks. The nicotine-rich group will receive 20 micrograms of nicotine per day through diet. Intervention 2: Control group:The control group will receive an iscaloric diet. Intervention 3: Intervention group: In this study, the Nicotine-rich diet with protein redistribution group will receive 20 micrograms of nicotine per day through the diet. In this group, 10 grams of protein will be consumed daily until the evening snack. After the evening meal, one gram of protein will be consumed per kilogram of body weight. 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 There is no more information
public Doctor Mohammadhasan Javanbakht
Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 4293 3057 mhjavan2001@yahoo.com Tehran University of Medical Sciences scientific Doctor Mohammadhasan Javanbakht
Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 4293 3057 mhjavan2001@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Parkinson's patients who have been diagnosed with Parkinson's disease according to the MDS clinical diagnostic criteria for Parkinson's disease Age over 50 years old Patients receiving dopaminergic therapy who have reached a stable dose to control symptoms Patients who have signed the consent form 50 years no limit Both Severe systemic or psychological disease History of gastrointestinal bleeding Taking aspirin with a dose of more than 325 mg per day Taking drugs that increase insulin sensitivity, heparin, warfarin or other anticoagulants and antiplatelets Exposure to cigarette smoke Alcohol consumption G20 Parkinson's disease Treatment - Other N/A Treatment - Other Intervention group: The duration of the intervention is 12 weeks. The nicotine-rich group will receive 20 micrograms of nicotine per day through diet. Control group:The control group will receive an iscaloric diet. Intervention group: In this study, the Nicotine-rich diet with protein redistribution group will receive 20 micrograms of nicotine per day through the diet. In this group, 10 grams of protein will be consumed daily until the evening snack. After the evening meal, one gram of protein will be consumed per kilogram of body weight. Evaluation of disease severity from the Unified Parkinson's Disease Rating Scale (UPDRS). Timepoint: At the beginning and end of the study. Method of measurement: Evaluation of disease severity from the Unified Parkinson's Disease Rating Scale (UPDRS). Tehran University of Medical Sciences Approved 2021-06-16 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Tehran University of Medical Sciences, Ghods St.,Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)