RecruitingPhase 2NCT07001150

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

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

Sponsor

Tanta University

Enrollment

50 participants

Start Date

May 10, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Min Age: 45 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria8

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.

Interventions

DRUGSilymarin

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.

DRUGlevodopa-carbidopa

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.