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

Phase 2RecruitingNCT07001150

Tanta University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

levodopa-carbidopaDRUG

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.

SilymarinDRUG

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta Hospital for Mental Health

Tanta, Tanta, Qism 2, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 months

Central Contacts

Nour Elsherbeny, MSc

CONTACT

01286911189 nelsherbeny@horus.edu.eg

Data from ClinicalTrials.gov

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