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IRCT20181006041247N1 IRCT 2021-01-03 Sanandaj University of Medical Sciences Effect of N-acetyl cysteine on Parkinson’s disease Effect of N-acetyl cysteine as an adjuvant therapy on Symptoms and Progression of Parkinson’s disease 2019-04-09 anticipated 40 Complete https://irct.ir/trial/34274 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is based on making blocks with size of 4 people, to divide participants into two groups: intervention group (A) and control group (B). So that, we divide all participants to four-sample blocks, and we allocate the block's samples equally between the two groups (e.g. ABAB). This pattern is the same in all blocks, Blinding description: Participants, clinical caregivers, outcome evaluators and data analyzers are not aware whether the therapeutic regimens include the drug or placebo. only the main researcher and pharmacist are aware of nature of therapeutic regimen based on codes given to the drug and placebo packages, earlier. 3 Parkinson's disease. Intervention 1: Intervention group: Parkinson's disease patients receive N-acetylcysteine for one year. two times per day, every time 600 mg. The medicine is consumed after breakfast and after dinner (one time per 12 hours). The medicine is made by Zambon Company, Switzerland. Intervention 2: Control group: Parkinson's disease patients receive the placebo for one year, two times per day. The placebo is consumed after breakfast and after dinner (one time per 12 hours). Yes - There is a plan to make this available What will be shared: Only a part of the data, probably Analyzed data can be accessed. When: The accession period is 6 months and starts after publishing the study results To whom: Researchers, Industry Conditions: The data can be used only for scientific citations. Any other use needs the permission of the RCT authorities. Where to obtain: Arman Rahimmi, Phone number: +989183718474, Email: armanrahimmi@gmail.com How to obtain: After communicating with Dr. Arman Rahimmi, the request will be processed within two weeks and the request will be responded according to the decisions. Comments:
public Arman Rahimmi
Amir Nezam Garoosi Street, Shahrak-e-Rah-o-Tarabari, Moalem Blvd., Feyz Abad Distict
Sanandaj Iran (Islamic Republic of) 6614988796 +98 87 3316 2929 armanrahimmi@gmail.com Sanandaj University of Medical Sciences scientific Arman Rahimmi
Amir Nezam Garoosi Street, Shahrak-e-Rah-o-Tarabari, Moalem Blvd., Feyz Abad Distict
Sanandaj Iran (Islamic Republic of) 6614988796 +98 87 3316 2929 armanrahimmi@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Patient's informed consent No brain surgery in the patient's post medical history 35 years 85 years Both having brain surgery within a year before starting the treatment period G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: Parkinson's disease patients receive N-acetylcysteine for one year. two times per day, every time 600 mg. The medicine is consumed after breakfast and after dinner (one time per 12 hours). The medicine is made by Zambon Company, Switzerland. Control group: Parkinson's disease patients receive the placebo for one year, two times per day. The placebo is consumed after breakfast and after dinner (one time per 12 hours). The quality of the patient's movement skills and intellectual function. Timepoint: Before and after the invention (one year). Method of measurement: Filling the Unified Parkinson's Disease Rating Scale (UPDRS) questionnaire according to the patient's interview and examining. Changes in dopaminergic areas within the patient's brain. Timepoint: Before and after the invention (one year). Method of measurement: Technetium-99m-Trodat-1 single-photon emission computerized tomography (SPECT). Sanandaj University of Medical Sciences Approved 2019-03-06 Ethics Committee of Kurdistan University of Medical Sciences Pasdaran Avenue Sanandaj Kurdistan Iran (Islamic Republic of)