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

NCT07001150 | Recruiting Phase 2

• 1 other identifier: 1331999
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale (UPDRS)

  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

  6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

25 patients who will receive their standard dopamine replacement therapy for 6 months

Drug: levodopa-carbidopa

Silymarin group

ACTIVE COMPARATOR

25 patients who will receive their standard dopamine replacement therapy plus silymarin 140mg three times daily for 6 months

Drug: levodopa-carbidopa; Drug: Silymarin

Interventions

levodopa-carbidopa DRUG

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.

Control group; Silymarin group

Silymarin DRUG

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.

Silymarin group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• Prof. Sahar Kamal Hegazy,Head of Clinical Pharmacy Department,Faculty of Pharmacy,Tanta University: collaborator
• Dr. Raed Ahmed Abdel-Maboud,Lecturer of neurology,Faculty of Medicine,Tanta University: collaborator

Study Sites (1)

Tanta Hospital for Mental Health

Tanta, Tanta, Qism 2, 31511, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination; Silymarin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Nour Elsherbeny, MSc

CONTACT

01286911189; nelsherbeny@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)