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IRCT20101209005352N2 IRCT 2018-08-31 Zanjan University of Medical Sciences The effectiveness of curcumin on quality of life, severity of illness, fatigue and sleep quality in Parkinson's patients The effectiveness of curcumin nanomicelles on quality of life, severity of illness, fatigue and sleep quality in Parkinson's patients 2018-08-23 anticipated 50 Complete https://irct.ir/trial/5726 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a restricted randomization using random allocation rule method was used. This method represents a large block for the entire sample size, which means that the balances in the number of people assigned to each of the groups will be at the end of the study. Therefore, a sample size of 50 was determined and randomly assigned 25 persons to group A and 25 persons to group B. SAS software for randomization was used. Sequential numbered, sealed, opaque envelopes were used to allocation concealment, Blinding description: 1. All patients know that there is two groups of patients that one group receiving drug and the other receiving pacebo but they did not know any information about receiving drug or placebo. 2. The nurse responsible for filling the evaluation form know that there is two groups of paients that receiving drug or pacebo but she did not know any information about who of yhem receiveing drug or placebo. 3 Parkinson's disease. Intervention 1: "Intervention group": Parkinson patients, two soft gelatin Sina-curcumin nanomicelle capsules of 80 mg after breakfast and dinner for three month , Exir Nano Sina company, Minoo comany, Curcumin the yellow pigment in curry spice , Tumeric, is the principal curcuminoid in the rhizome of Curcumia longa Linn. Curcumin has effects similar to other polyphenols (diarylheptanoid). In combination with other main curcuminoids including desmethoxycurcumin, bis-desmethoxycurumin, they form 3-5% ofdried tumeric powder. Intervention 2: "Control group": Parkinson patients, two soft gelatin placebo Sina-curcumin nonomicelle capsules of 80 mg after breakfast and dinner for three month, Exir Nano Sina company, Minoo company. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after the removal of the patient's name. When: The start of the access period is 6 months after the results are published. To whom: Data will only be available to academic researchers. Conditions: Different analyses are available for academic researchers. Where to obtain: Dr. Mehdi Moghbouli, Vali-e-Asr Square, Vali-e-Asr hospital, Zanjan, 4515777978 Iran, Tel: 00982433770801, e-mail address: m.maghbooli@zums.ac.ir How to obtain: Send request via email - Duration of sending data: two weeks Comments:
public Mehdi Maghbooli
Vali-e-Asr Squ., Vali-e-Asr hospital
Zanjan Iran (Islamic Republic of) 4515777978 +98 24770801 m.maghbooli@zums.ac.ir Zanjan University of Medical Sciences scientific Mehdi Maghbooli
Neurology department, Vali-e-Asr Hospital, Vali-e-Asr Squ.
Zanjan Iran (Islamic Republic of) 4515777978 +98 24770801 m.maghbooli@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Idiopathic Parkinson disease (MDS-PD Criteria) At least elementary education Filling up the consent form for each patient Unified Parkinson's Disease Rating Scale (Hoehn &Yahr) (I- III) No change in drug and supplement therapy since last month 35 yrs and over No reported allergy to turmeric and other foods and supplements Parkinson's disease history <10 years 35 years no limit Both Abnormal renal and liver function tests Cognitive disorders, epilepsy, stroke, and other cerebral diseases Severe disability caused by dementia or other diseases Gastric disorders, GE reflux and gastric ulcers G20 Parkinson's disease Treatment - Drugs Placebo "Intervention group": Parkinson patients, two soft gelatin Sina-curcumin nanomicelle capsules of 80 mg after breakfast and dinner for three month , Exir Nano Sina company, Minoo comany, Curcumin the yellow pigment in curry spice , Tumeric, is the principal curcuminoid in the rhizome of Curcumia longa Linn. Curcumin has effects similar to other polyphenols (diarylheptanoid). In combination with other main curcuminoids including desmethoxycurcumin, bis-desmethoxycurumin, they form 3-5% ofdried tumeric powder. "Control group": Parkinson patients, two soft gelatin placebo Sina-curcumin nonomicelle capsules of 80 mg after breakfast and dinner for three month, Exir Nano Sina company, Minoo company. Quality of life based on the PDQ-39 questionnaire. Timepoint: Filling up the questionnaire for each patient at the beginning of the study and three months later. Method of measurement: The quality of life based on the PDQ-39. Sleep quality. Timepoint: Filling up the questionnaire for each patient at the beginning of the study and three month later. Method of measurement: The sleep quality based on PSQI questionnaire. Fatigue. Timepoint: Filling up the questionnaire for each patient at the beginning of the study and three month later. Method of measurement: The fatigue based on FSS questionnaire. Zanjan University of Medical Sciences Approved 2018-01-02 Ethics committee of Zanjan University of Medical Sciences Vali-e-Asr Squ., Vali-e-Asr hospital Zanjan Zanjan Iran (Islamic Republic of)