Parkinson Disease
Conditions
Brief summary
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.
Detailed description
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. First, the suspected PD patients will be evaluated by a neurologist in the neurology department. The proposed study will be conducted among outdoor patients with Parkinson's disease in the PD clinic, will be made clinically using to scale by an expert neurologist following inclusion and exclusion criteria.
Interventions
melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks
Sponsors
Bangladesh Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the level of oxidative stress markers | 0 week and 12 weeks | To compare the level of oxidative stress markers including MDA and GSH in levodopa-treated PD patients |
| the serum hs-CRP level | 0 weeks and12 weeks | To estimate and compare the serum hs-CRP level in levodopa-treated PD patients |
| using the MDS-UPDRS (Part-II) | 0 week and 12 weeks | To assess and compare the severity score of motor activity in Levodopa treated PD patients |
Countries
Bangladesh
Contacts
PRINCIPAL_INVESTIGATORFarzana Akter, MBBS
Bangladesh Medical University
Outcome results
None listed