Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease

Phase 2

Recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: levodopa-carbidopa; Drug: Silymarin

• Registration Number: NCT07001150
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Status Verified: 2025-06
• Study First Posted: 2025-06-03
• Last Update Submitted: 2025-06-28
• Study Start: 2025-06-30
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age between 45 and 65 years old
• Both sexes
• Patients with Parkinson's disease on dopamine replacement therapy
• Modified Hoehn and Yahr stage, MHY 1-4 (29)

Exclusion Criteria

• Subjects < 18 years of age
• Pregnant or breastfeeding women
• Suspected hypersensitivity to silymarin or multivitamins
• Advanced liver disease (e.g., ascites, bleeding esophageal varices, and hepatic encephalopathy)
• Subjects with morbid obesity, i.e., a Body Mass Index (BMI) > 40
• Subjects with severe illness, e.g., multisystem failure, cancer, or poorly controlled diabetes, i.e., known diabetic with Hemoglobin A1C (HbA1C)>7%
• Current use of Silymarin or recent use within the past two weeks.
• Other conditions, which, in the opinion of the investigators, make the patient unsuitable for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	levodopa-carbidopa	25 patients who will receive their standard dopamine replacement therapy for 6 months
Silymarin group	levodopa-carbidopa	25 patients who will receive their standard dopamine replacement therapy plus silymarin 140mg three times daily for 6 months
Silymarin group	Silymarin	25 patients who will receive their standard dopamine replacement therapy plus silymarin 140mg three times daily for 6 months

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS)	6 months	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

Trial Locations

Locations (1)

Tanta Hospital for Mental Health; 🇪🇬 Tanta, Tanta, Qism 2, Egypt