Skip to main content
Clinical Trials/NCT07001150
NCT07001150RecruitingPhase 2

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

Tanta University1 site in 1 country50 target enrollmentStarted: May 10, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
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

Active Comparator

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

Intervention: Silymarin (Drug)

Control group

Active Comparator

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

Intervention: levodopa-carbidopa (Drug)

Silymarin group

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nour Amr Ahmed Mosaad Elsherbeny

Teaching Assistant

Tanta University

Study Sites (1)

Loading locations...

Similar Trials