Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-12 @ 8:15 AM
Study NCT ID:
NCT07375693
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-29
First Post:
2025-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients
Sponsor:
Bangladesh Medical University
Organization:
Study Overview
Official Title:
Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: