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

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Silymarin; Drug: levodopa-carbidopa

Study type: Interventional

Funder types: Other

Identifiers

NCT07001150

1331999

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: levodopa-carbidopa

Silymarin group

Active Comparator group

Description:

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

Treatment:

Drug: levodopa-carbidopa

Drug: Silymarin