Parkinson's Disease (PD)
Conditions
Keywords
Parkinson's Disease, N-acetylcysteine
Brief summary
This is a study on Parkinson's disease patients, referred to Tohid Hospital of Sanandaj City. The patients receive N-acetylcysteine for one year. The efficacy of the Drug is evaluated based on clinical interview, filling Unified Parkinson's Disease Rating Scale (UPDRS) questionnaire, and single-photon emission computerized tomography (SPECT) brain imaging. The only person who has not been blinded for the study is the supplier of the drug and placebo. Inclusion criteria: Patient's informed consent Exclusion criteria: Having brain surgery within a year before the initiation of the intervention. Medication group: receiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg. placebo group: receiving a placebo with similar appearance, color, odor, and taste like real medication.
Detailed description
This is a randomized double-blinded clinical trial. 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. 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.
Interventions
Parkinson's disease patients receive NAC (1200 mg/day) for one year.
DRUGPlacebo
Parkinson's disease patients receive Placebo similar to the real drug, with no active ingredient
Sponsors
Kurdistan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized double-blinded clinical trial study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient's informed consent No brain surgery in the patient's post medical history
Exclusion criteria
* having brain surgery within a year before starting the treatment period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| single-photon emission computerized tomography (SPECT) brain imaging | one year | Also known as TRODAT scan or DaTscan, is a nuclear medicine imaging procedure that helps diagnose and evaluate Parkinson's disease by assessing the function of dopamine transporters in the brain. It specifically visualizes the dopaminergic system, which is affected in Parkinson's disease. |
| Unified Parkinson's Disease Rating Scale (UPDRS) | one year for each PD patient (at baseline and after one year) | It is a questionnaire to assess the severity and progression of Parkinson's disease. |
Countries
Iran
Outcome results
None listed