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Recruiting NCT07001150

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

Phase II Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: levodopa-carbidopa, Silymarin.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

  • Drug levodopa-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.
  • Drug Silymarin
    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.

Primary outcome measures

  • Unified Parkinson's Disease Rating Scale (UPDRS) [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta Hospital for Mental Health — Tanta

Identifiers

NCT: NCT07001150 · 1331999

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗