Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-04-05 @ 3:31 AM
Study NCT ID:
NCT07001150
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C009265', 'term': 'carbidopa, levodopa drug combination'}, {'id': 'D012838', 'term': 'Silymarin'}], 'ancestors': [{'id': 'D044947', 'term': 'Flavonolignans'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-05-23', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': '6 months', 'description': "The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating tool used to determine the severity and progression of Parkinson's disease in patients"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is a leading neurodegenerative movement disorder, marked by a gradual loss of dopamine-producing neurons in the substantia nigra pars compacta (SNpc) and the accumulation of α-synuclein protein aggregates. Silymarin, a polyphenolic flavonoid renowned for its potent antioxidant properties, will be studied for its neuroprotective effects in PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 45 and 65 years old\n* Both sexes\n* Patients with Parkinson's disease on dopamine replacement therapy\n* Modified Hoehn and Yahr stage, MHY 1-4 (29)\n\nExclusion Criteria:\n\n* Subjects \\< 18 years of age\n* Pregnant or breastfeeding women\n* Suspected hypersensitivity to silymarin or multivitamins\n* Advanced liver disease (e.g., ascites, bleeding esophageal varices, and hepatic encephalopathy)\n* Subjects with morbid obesity, i.e., a Body Mass Index (BMI) \\> 40\n* Subjects with severe illness, e.g., multisystem failure, cancer, or poorly controlled diabetes, i.e., known diabetic with Hemoglobin A1C (HbA1C)\\>7%\n* Current use of Silymarin or recent use within the past two weeks.\n* Other conditions, which, in the opinion of the investigators, make the patient unsuitable for enrollment."}, 'identificationModule': {'nctId': 'NCT07001150', 'briefTitle': "Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': "Clinical Study Evaluating the Possible Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease", 'orgStudyIdInfo': {'id': '1331999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '25 patients who will receive their standard dopamine replacement therapy for 6 months', 'interventionNames': ['Drug: levodopa-carbidopa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Silymarin group', 'description': '25 patients who will receive their standard dopamine replacement therapy plus silymarin 140mg three times daily for 6 months', 'interventionNames': ['Drug: levodopa-carbidopa', 'Drug: Silymarin']}], 'interventions': [{'name': 'levodopa-carbidopa', 'type': 'DRUG', 'description': "Carbidopa/levodopa is a combination of two medications: carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease. The main and most effective treatment strategy for motor symptoms in Parkinson's disease relies on replenishing dopamine levels through the use of L-dopa.", 'armGroupLabels': ['Control group', 'Silymarin group']}, {'name': 'Silymarin', 'type': 'DRUG', 'description': 'Silymarin, a polyphenolic flavonoid renowned for its potent antioxidant properties, is employed clinically for managing hepatic disorders. Its antioxidant effects are primarily attributed to its ability to scavenge free radicals.', 'armGroupLabels': ['Silymarin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Tanta', 'state': 'Tanta, Qism 2', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nour A Elsherbeny, Bachelor of Pharmacy', 'role': 'CONTACT', 'email': 'nelsherbeny@horus.edu.eg', 'phone': '01286911189'}, {'name': 'Nour A Elsherbeny, Bachelor of Pharmacy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tanta Hospital for Mental Health', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Nour Elsherbeny, MSc', 'role': 'CONTACT', 'email': 'nelsherbeny@horus.edu.eg', 'phone': '01286911189', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Sahar Kamal Hegazy,Head of Clinical Pharmacy Department,Faculty of Pharmacy,Tanta University', 'class': 'UNKNOWN'}, {'name': 'Dr. Raed Ahmed Abdel-Maboud,Lecturer of neurology,Faculty of Medicine,Tanta University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Nour Amr Ahmed Mosaad Elsherbeny', 'investigatorAffiliation': 'Tanta University'}}}}