Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-05 @ 2:47 PM
Study NCT ID:
NCT07375693
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-29
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-02-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-26', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '0 week and 12 weeks', 'description': 'To evaluate the effect of melatonin on oxidative stress, neuroinflammation, and the improvement of symptoms in levodopa-treated PD patients.'}], 'secondaryOutcomes': [{'measure': 'the level of oxidative stress markers', 'timeFrame': '0 week and 12 weeks', 'description': 'To compare the level of oxidative stress markers including MDA and GSH in levodopa-treated PD patients'}, {'measure': 'the serum hs-CRP level', 'timeFrame': '0 weeks and12 weeks', 'description': 'To estimate and compare the serum hs-CRP level in levodopa-treated PD patients'}, {'measure': 'using the MDS-UPDRS (Part-II)', 'timeFrame': '0 week and 12 weeks', 'description': 'To assess and compare the severity score of motor activity in Levodopa treated PD patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "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:\n\nIn 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.\n\nParticipants will:\n\nTake 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.", 'detailedDescription': "This research will be conducted in the Department of Pharmacology in collaboration with the Department of Neurology, at Bangabandhu Sheikh Mujib Medical University.\n\nPatients will be recruited from the PD clinic, OPD at Department of Neurology.\n\nStudy procedure:\n\nMild 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.\n\nTotal 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.\n\nFirst, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosesd Parkinson's disease patients taking levodopa\n* mild to moderate PD pt according to Hohen and Yahr staging, stage-I,II,III\n* age:\\>45 years\n* both male and female\n\nExclusion Criteria:\n\n* secondary causes of PD\n* Prior stereotactic surgery for PD\n* suffering from active malignancy\n* known hypersensitivity to melatonin\n* Patients taking anticonvulsants, OCP, DMARD\n* pt with autoimmune disease\n* pregnancy or lactating mother\n* has any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed"}, 'identificationModule': {'nctId': 'NCT07375693', 'briefTitle': "Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients", 'organization': {'class': 'OTHER', 'fullName': 'Bangladesh Medical University'}, 'officialTitle': "Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.", 'orgStudyIdInfo': {'id': 'BSMMU/2025/4251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'participants received Melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks', 'interventionNames': ['Drug: MELATONIN (MELATL07959)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'participants received placebo for 12 weeks', 'interventionNames': ['Drug: MELATONIN (MELATL07959)']}], 'interventions': [{'name': 'MELATONIN (MELATL07959)', 'type': 'DRUG', 'otherNames': ['Tab. melatonin 10 mg'], 'description': 'melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks', 'armGroupLabels': ['Intervention group', 'placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1212', 'city': 'Dhaka', 'state': 'Dhaka Division', 'country': 'Bangladesh', 'facility': 'Bangladesh medical university', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Farzana Akter, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bangladesh Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangladesh Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Dr. Farzana Akter', 'investigatorAffiliation': 'Bangladesh Medical University'}}}}