The effectiveness of curcumin nanomicelles on quality of life, severity of illness, fatigue and sleep quality in Parkinson's patients

Determining the effect of curcumin nanomicelles on quality of life, severity of illness, fatigue and sleep quality in Parkinson's patients

Two arm parallel group randomized trial with blinded postoperative care and outcome assessment. A restricted randomization using random allocation rule method was used. Sequential numbered, sealed, opaque envelopes were used to allocation concealment.

Two-blind randomized clinical trial, and pre- and post-tests with control group. A total of 50 patients who were referred to Vali-e-Asr Hospital in Zanjan were selected and randomly divided into two experimental groups. All patients, referral physician, nurse, statistician, and the person responsible for drafting manuscript did not know any information about drug or placebo. Quality of life, fatigue, and sleep quality are based on PDQ-39 questionnaire, FSS, and PSQI, respectively. Two soft gelatin capsules of 80 mg after breakfast and dinner for three months are consumed.

Inclusion criteria Idiopathic Parkinson's 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 Exclusion criteria 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

Experimental (25 patients) and placebo (25 patients) groups, who, in addition to regular treatment, received curcumin and placebo , respectively, for three months.

Quality of life

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.

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.

The total potential data can be shared after the removal of the patient's name.

The start of the access period is 6 months after the results are published.

Data will only be available to academic researchers.

Different analyses are available for academic researchers.

Dr. Mehdi Moghbouli, Vali-e-Asr Square, Vali-e-Asr hospital, Zanjan, 4515777978 Iran, Tel: 00982433770801, e-mail address: m.maghbooli@zums.ac.ir

Send request via email - Duration of sending data: two weeks