Clinical Study Evaluating the Possible Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Unified Parkinson's Disease Rating Scale (UPDRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Silymarin group
25 patients who will receive their standard dopamine replacement therapy plus silymarin 140mg three times daily for 6 months
Intervention: Silymarin (Drug)
Control group
25 patients who will receive their standard dopamine replacement therapy for 6 months
Intervention: levodopa-carbidopa (Drug)
Silymarin group
25 patients who will receive their standard dopamine replacement therapy plus silymarin 140mg three times daily for 6 months
Intervention: levodopa-carbidopa (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Nour Amr Ahmed Mosaad Elsherbeny
Teaching Assistant
Tanta University