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IRCT20171123037600N1 IRCT 2018-06-08 Mashhad University of Medical Sciences Effectiveness of Curcumin in patients with Parkinson's disease Evaluation of Curcumin as add-on therapy in patients with Parkinson's disease on MDS-UPDRS scale: A Randomized Double-blind Placebo-controlled Trial 2018-05-22 anticipated 60 Complete https://irct.ir/trial/28424 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study we will use simple randomization and sealed envelopes. Patients are allocated based on selection of envelopes with "drug group" or "placebo group" written inside and are randomly arranged by another person other than researcher or data analyzer. allocation concealment is reached through randomization via sealed envelopes that randomly arranged and selected by third person who is giving drug or placebo to the patients, Blinding description: Patients, researcher, outcome assessor and data analyzer are blind to patient allocation to research groups. The randomly selected envelope is received by an oriented person other than researcher, outcome assessor or data analyzer who give the patients drug or placebo. Patients, researcher, outcome assessor and data analyzer never get access to the allocation information until the end of study. 3 Parkinson's disease. Intervention 1: Intervention group: Curcumin in form of nanomicelles (SinaCurcumin) as add-on therapy for 9 months with 80mg/day dosage. Intervention 2: Control group: Placebo drug identical to SinaCurcumin is given to patients beside their dopaminergic treatment for 9 months daily. Yes - There is a plan to make this available What will be shared: These files could be available upon request: Patients' data after removing their identity Research protocol Statistical methods used in this study Informed consent file Research study report Codes used for allocating and data analyzing data categorizing file When: data availability would begin 3 months after article has been published To whom: Any researcher who needs our data to accomplish his research Conditions: Researcher should use these data only in their related research and mention the reference Where to obtain: researchers should send their request to Mr. Hamidreza Ghodsi by email or mail post. Email: ghodsihr901@mums.ac.ir Address: Block 9, North Kowsar street 3rd, Mashhad, Iran How to obtain: Researchers should send their request with information about their goals and protocol of their study and how our data is needed for their results. requests will be responded in 14 working days. Comments:
public Hamidreza Ghodsi
No 9, North Kowsar 3, Valkilabad Blvd., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9178684993 +98 51 3883 3080 Ghodsihr901@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Shoeibi
No. 5, Samaneh street 21, Ferdowsi Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 91786864993 +98 51 3763 6928 shoeibia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients who are diagnosed with Parkinson's disease based on MDS clinical diagnostic criteria for Parkinson's disease and at least 30 years of age Patients who are receiving dopaminergic treatment and their symptoms are under control Patients with signed informed consent 30 years no limit Both Severe systemic or psychologic disease History of Gastrointestinal bleeding Aspirin use over 325mg/day, any anticoagulant or anti-platelet drug use such as heparin or warfarin, antioxidant use except vitamin E up to 2000 IU/day and vitamin C up to 500mg/day G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: Curcumin in form of nanomicelles (SinaCurcumin) as add-on therapy for 9 months with 80mg/day dosage Control group: Placebo drug identical to SinaCurcumin is given to patients beside their dopaminergic treatment for 9 months daily Patients score in MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating) scale. Timepoint: beginning of study, 3 months after drug initiation, 6 months after drug initiation, 9 months after drug initiation. Method of measurement: MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating) scale which is a based on standard questionnaire, interview and neurological examination of the patients. Vice chancellor of research and technology of Mashhad University of Medical Sciences Approved 2017-07-05 Ethics committee of Mashhad University of Medical Sciences Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)