Effect of N-acetyl Cysteine as an Adjuvant Therapy on Symptoms and Progression of Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's informed consent No brain surgery in the patient's post medical history
排除标准
- •having brain surgery within a year before starting the treatment period
研究组 & 干预措施
Medication group
Receiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg
干预措施: N-Acetylcysteine (NAC) Treatment (Drug)
Placebo group
Receiving a placebo with similar appearance, color, odor, and taste like real medication
干预措施: Placebo (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: 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.
single-photon emission computerized tomography (SPECT) brain imaging
时间窗: 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.
次要结局
未报告次要终点
研究者
Arman Rahimmi
Assistant Professor
Kurdistan University of Medical Sciences