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NCT Number: NCT07001150

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

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.

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Key information

Conditions

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

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta Hospital for Mental Health

Tanta, Tanta, Qism 2, 31511, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: 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

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

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

Registry information

Official study title

Clinical Study Evaluating the Possible Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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