Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Migration, Crosslink

📖

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

active

wiki page Created: 2026-04-02T07:19:04 By: crosslink-migration Quality: 50% ✓ SciDEX ID: wiki-clinical-trials-silymarin-parkinson

📖 Wiki Page

clinical_trial694 wordssynced 2026-04-02

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Trial Overview

flowchart TD clinical_trials_silymarin_park["Silymarin for Neuroprotection and Symptom Manage"] clinical_trials_silymarin_park["Neuroprotection"] clinical_trials_silymarin_park -->|"related to"| clinical_trials_silymarin_park style clinical_trials_silymarin_park fill:#81c784,stroke:#333,color:#000 clinical_trials_silymarin_park["Symptom"] clinical_trials_silymarin_park -->|"related to"| clinical_trials_silymarin_park style clinical_trials_silymarin_park fill:#81c784,stroke:#333,color:#000 clinical_trials_silymarin_park["Management"] clinical_trials_silymarin_park -->|"related to"| clinical_trials_silymarin_park style clinical_trials_silymarin_park fill:#81c784,stroke:#333,color:#000 clinical_trials_silymarin_park["Trial"] clinical_trials_silymarin_park -->|"related to"| clinical_trials_silymarin_park style clinical_trials_silymarin_park fill:#81c784,stroke:#333,color:#000 style clinical_trials_silymarin_park fill:#4fc3f7,stroke:#333,color:#000

| 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 |

Study Design

...

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Trial Overview

Mermaid diagram (expand to render)

| 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 |

Study Design

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.

Mechanism

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

Inclusion Criteria

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

Exclusion Criteria

Current use of silymarin or milk thistle supplements
Known allergy to Asteraceae plants
Severe liver disease
Coexisting neurological conditions

Outcome Measures

Primary Outcomes

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I-III score
Change in plasma antioxidant capacity

Secondary Outcomes

Motor symptom fluctuations assessment
Non-motor symptom questionnaire scores
Quality of life measures (PDQ-39)

Clinical Significance

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.

Silymarin Pharmacology

Chemical Composition

Silymarin is a complex mixture of flavonolignans extracted from [silybum marianum](/entities/milk-thistle) (milk thistle), with silibinin (also called silymarin) being the most biologically active component[@silymarinmech]. The standardized extract typically contains:

Silibinin (70-80%): The major active component, consisting of two diastereomers, silybin A and silybin B
Isosilybin: Minor but biologically active flavonolignan
Silydianin and silychristine: Additional flavonolignans with antioxidant properties
Flavonoids: Taxifolin and other polyphenolic compounds

Pharmacokinetics

Absorption: Poor oral bioavailability due to extensive first-pass metabolism
Distribution: Crosses the blood-brain barrier to some extent
Metabolism: Hepatic metabolism via CYP450 enzymes
Excretion: Primarily biliary excretion

Preclinical Evidence in PD Models

Animal Studies

Multiple preclinical studies have demonstrated silymarin's neuroprotective effects in PD models[@pdneuroinflammation]:

6-OHDA model: Reduced dopaminergic neuron loss and improved behavioral outcomes

MPTP model: Protected against MPTP-induced parkinsonism

α-synuclein models: Reduced aggregation and protected neurons

Mechanistic Studies

The neuroprotective mechanisms include[@mitchondrial][@antioxidant]:

Upregulation of Nrf2 pathway and antioxidant enzymes
Inhibition of microglia activation and reduced pro-inflammatory cytokines
Preservation of mitochondrial complex I activity
Anti-apoptotic effects through modulation of Bcl-2 family proteins

Comparison with Other Antioxidant Approaches

| Agent | Mechanism | Clinical Stage | Evidence Level |
|-------|-----------|----------------|----------------|
| Silymarin | Antioxidant, anti-inflammatory, mitochondrial | Phase 2 | Moderate preclinical |
| CoQ10 | Mitochondrial electron chain | Phase 3 (completed) | Mixed results |
| Vitamin E | Lipid antioxidant | Phase 3 | No benefit |
| Curcumin | Antioxidant, anti-inflammatory | Phase 2 | Preliminary |

Trial Design Considerations

Strengths

Repurposing potential: If proven effective, silymarin could be quickly translated to clinical use

Safety profile: Excellent tolerability established from decades of use in liver diseases

Cost-effectiveness: Low-cost intervention accessible to broad patient populations

Multi-target approach: Addresses oxidative stress, inflammation, and mitochondrial dysfunction simultaneously

Limitations

Variable composition: Natural product extracts can vary in active component concentrations

Bioavailability: Poor oral bioavailability may limit brain penetration

Single-arm design: Lack of placebo control limits causal inferences

[Parkinson's Disease](/diseases/parkinsons-disease)
[Neuroprotection in Parkinson's Disease](/therapeutics/neuroprotection)
[Oxidative Stress in Neurodegeneration](/mechanisms/oxidative-stress-neurodegeneration)
[CoQ10 for PSP](/clinical-trials/coq10-psp-nice-nct04564555)
[Antioxidant Therapies for Neurodegeneration](/therapeutics/antioxidant-therapies)

References

[ClinicalTrials.gov: NCT07001150](https://clinicaltrials.gov/study/NCT07001150)

[Silymarin: A comprehensive review of its pharmacology and therapeutic potential in neurological disorders (2023)](https://doi.org/10.1002/ptr.7891)

[Neuroinflammation in Parkinson's disease: mechanisms and therapeutic targets (2024)](https://doi.org/10.1186/s12974-024-03058-w)

[Mitochondrial dysfunction in Parkinson's disease: From pathogenesis to therapeutic targets (2023)](https://doi.org/10.1016/j.freeradbiomed.2023.02.012)

[Oxidative stress in neurodegenerative diseases: role of antioxidants (2024)](https://doi.org/10.3390/antiox13030345)

Pathway Diagram

The following diagram shows the key molecular relationships involving Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150) discovered through SciDEX knowledge graph analysis:

Mermaid diagram (expand to render)

📖 View canonical wiki page →

Related Entities

clinical-trials-silymarin-parkinson-nct07001150

▸Metadataorigin_type: v1_polymorphic_backfill

slug	clinical-trials-silymarin-parkinson-nct07001150
kg_node_id	None
entity_type	clinical_trial
origin_type	v1_polymorphic_backfill
source_table	wiki_pages
wiki_page_id	wp-42a0ee5c2919
__merged_from	{'merged_at': '2026-05-13', 'unprefixed_id': 'clinical-trials-silymarin-parkinson-nct07001150'}
_schema_version	1

📊 Evidence Profile Foundational

Evidence Balance

+0%

Certainty

100%

Debates

0

Incoming

2165

Outgoing

2166

0 supporting 0 contradicting 0 neutral

View full evidence profile →

Public annotations (0)Annotate on Hypothes.is →

No public annotations yet.

📗 Cite This Artifact

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Trial Overview

Study Design

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Trial Overview

Study Design

Mechanism

Inclusion Criteria

Exclusion Criteria

Outcome Measures

Primary Outcomes

Secondary Outcomes

Clinical Significance

Silymarin Pharmacology

Chemical Composition

Pharmacokinetics

Preclinical Evidence in PD Models

Animal Studies

Mechanistic Studies

Comparison with Other Antioxidant Approaches

Trial Design Considerations

Strengths

Limitations

References

Pathway Diagram

💬 Discussion

📗 Cite This Artifact

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Trial Overview

Study Design

Silymarin for Neuroprotection and Symptom Management in Parkinson's Disease (NCT07001150)

Trial Overview

Study Design

Mechanism

Inclusion Criteria

Exclusion Criteria

Outcome Measures

Primary Outcomes

Secondary Outcomes

Clinical Significance

Silymarin Pharmacology

Chemical Composition

Pharmacokinetics

Preclinical Evidence in PD Models

Animal Studies

Mechanistic Studies

Comparison with Other Antioxidant Approaches

Trial Design Considerations

Strengths

Limitations

Related Pages

References

Pathway Diagram

💬 Discussion