¶ Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)
| Field |
Value |
| NCT ID |
NCT07001150 |
| Status |
Recruiting |
| Phase |
Phase 2 |
| Sponsor |
Tanta University |
| Enrollment |
50 participants |
| Start Date |
March 15, 2024 |
| Completion Date |
March 2026 |
This single-arm Phase 2 trial evaluates the neuroprotective and symptomatic effects of silymarin (standardized milk thistle extract) in patients with Parkinson's Disease. Silymarin is a mixture of flavonolignans including silibinin, known for its potent antioxidant and anti-inflammatory properties.
Silymarin acts through multiple neuroprotective pathways:
- Antioxidant activity: Scavenges free radicals and enhances endogenous antioxidant defenses (glutathione, SOD)
- Anti-inflammatory effects: Inhibits NF-κB signaling and reduces pro-inflammatory cytokine production
- Mitochondrial protection: Helps maintain mitochondrial membrane potential and ATP production
- Neurogenesis promotion: May support dopaminergic neuron survival and function
- Age 40-75 years
- Diagnosed with Parkinson's Disease (UK Brain Bank criteria)
- Hoehn & Yahr stage 1-3
- On stable PD medication for at least 4 weeks
- MMSE score ≥ 24
- Current use of silymarin or milk thistle supplements
- Known allergy to Asteraceae plants
- Severe liver disease
- Coexisting neurological conditions
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I-III score
- Change in plasma antioxidant capacity
- Motor symptom fluctuations assessment
- Non-motor symptom questionnaire scores
- Quality of life measures (PDQ-39)
Silymarin represents a repurposed nutraceutical approach to neuroprotection in PD. If successful, this trial could establish a low-cost, widely-available neuroprotective strategy for PD patients.
- ClinicalTrials.gov: NCT07001150