Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- effect of melatonin 2) Antioxidant marker erythrocyte glutathione (GSH) This study involves a comparison of MDA and GSH levels between the control and intervention groups at baseline and after 12 weeks.
研究概览
简要总结
In Bangladesh Melatonin is currently used for insomnia. Its potential therapeutic benefits beyond sleep regulation. This study aimss to evaluate the effects of melatonin supplementation on oxidative stress markers, neuroinflammation and clinical outcomes in patients with Parkinson's disease. The main question it aims to answer:
In patients with Parkinson's disease receiving levodopa, does melatonin supplementation, compared to levodopa treatment alone, improve the symptoms of PD over a 12 week of period.
Participants will:
Take Melatonin 10mg or placebo everyday for 3 months at night 30minutes before bedtime. Visit the clinic once every 6 weeks for checkups and tests keep a diary of their symptoms,UPDRS score. At the end of 12 weeks will reaper hs-CRP, MDA and GSH.
详细描述
This research will be conducted in the Department of Pharmacology in collaboration with the Department of Neurology, at Bangabandhu Sheikh Mujib Medical University.
Patients will be recruited from the PD clinic, OPD at Department of Neurology.
Study procedure:
Mild to moderate Parkinson's disease patients receiving levodopa according to Hoehn and Yahr staging, stage -I, II, Ill will be selected from the outpatient department of the Neurology, BSMMU. The objective, nature, purpose and potential risk of all the procedures used for the study will be explained in detail to each subject, with a cordial attitude emphasizing the benefits he/she might obtain from this study.
Total of 70 patients will be assessed. Informed written consent from each patient will be taken in a prescribed form. Then demographic Information, address, mobile number, and medical history will be recorded in a preformed data schedule. For giving intervention, patients will be divided into two groups group A and group B by randomization. A total of 70 patients will be randomized, for (group A n=35) and Group B (n=35). At baseline, the MDS-UPDRS score will be evaluated by the present researcher and 6 ml blood will be collected for the baseline measurement of MDA, GSH, and hs-CRP levels. Then patients will be assigned to the respective groups. Tab. Melatonin 10mg/day (1 tablet 1 hour before bedtime) will be given to the patient of group A for 12 weeks and Tab. Placebo will be given to the patient of group B for 12 weeks. Regular medicine intake will be confirmed by talking to the patients or the care giver over the telephone and from the compliance sheet of the patients. The disease severity will be assessed by MDS-UPDRS(Part-II) score at the end of the12 weeks treatment. 6 ml blood will be collected to measure MDA, GSH and hs-CRP levels at the end of the 12 weeks of treatment. Patients will be asked to report any unwanted effects of the medicine like excessive fatigue, depression and weight loss given during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosesd Parkinson's disease patients taking levodopa
- •mild to moderate PD pt according to Hohen and Yahr staging, stage-I,II,III
- •age:>45 years
- •both male and female
排除标准
- •secondary causes of PD
- •Prior stereotactic surgery for PD
- •suffering from active malignancy
- •known hypersensitivity to melatonin
- •Patients taking anticonvulsants, OCP, DMARD
- •pt with autoimmune disease
- •pregnancy or lactating mother
- •has any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed
研究组 & 干预措施
Intervention group
participants received Melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks
干预措施: MELATONIN (MELATL07959) (Drug)
placebo group
participants received placebo for 12 weeks
干预措施: MELATONIN (MELATL07959) (Drug)
结局指标
主要结局
effect of melatonin 2) Antioxidant marker erythrocyte glutathione (GSH) This study involves a comparison of MDA and GSH levels between the control and intervention groups at baseline and after 12 weeks.
时间窗: 0 week and 12 weeks
To evaluate the effect of melatonin on oxidative stress, neuroinflammation, and the improvement of symptoms in levodopa-treated PD patients.
次要结局
- the level of oxidative stress markers(0 week and 12 weeks)
- the serum hs-CRP level(0 weeks and12 weeks)
- using the MDS-UPDRS (Part-II)(0 week and 12 weeks)
研究者
Dr. Farzana Akter
principal investigator
Bangladesh Medical University