Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients

NCT07375693 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: BSMMU/2025/4251
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  To evaluate the effect of melatonin on oxidative stress, neuroinflammation, and the improvement of symptoms in levodopa-treated PD patients.

  0 week and 12 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

participants received Melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks

Drug: MELATONIN (MELATL07959)

placebo group

PLACEBO COMPARATOR

participants received placebo for 12 weeks

Drug: MELATONIN (MELATL07959)

Interventions

MELATONIN (MELATL07959) DRUG

melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks

Also known as: Tab. melatonin 10 mg

Intervention group; placebo group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh medical university

Dhaka, Dhaka Division, 1212, Bangladesh

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Farzana Akter, MBBS

  Bangladesh Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 29, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): August 23, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)