Silymarin for protecting nerves and easing Parkinson's symptoms
Clinical Study Evaluating the Possible Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease
PHASE2 · Tanta University · NCT07001150
This Phase 2 trial will test whether adding silymarin to standard levodopa‑carbidopa helps protect brain cells and improve symptoms in people aged 45–65 with Parkinson's disease.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Tanta, Tanta, Qism 2) |
| Trial ID | NCT07001150 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial enrolls adults with Parkinson's disease who are already on dopamine replacement therapy and in modified Hoehn and Yahr stages 1–4. Participants will receive silymarin in addition to their routine levodopa‑carbidopa treatment and will be followed for changes in motor symptoms, safety, and tolerability. Key exclusions include pregnancy, advanced liver disease, morbid obesity, poorly controlled diabetes, and recent or current use of silymarin. The study is conducted at a single site where investigators will monitor clinical outcomes and adverse events during the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45–65 with Parkinson's disease who are taking dopamine replacement therapy and are in modified Hoehn and Yahr stages 1–4.
Not a fit: People who are pregnant or breastfeeding, have advanced liver disease, morbid obesity (BMI >40), poorly controlled diabetes, or recent/current silymarin use are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, adding silymarin could slow neuronal damage and lead to better symptom control for people with Parkinson's disease.
How similar studies have performed: Preclinical studies suggest silymarin has antioxidant and neuroprotective effects, but clinical evidence in Parkinson's disease is limited and not yet well established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, Tanta, Qism 2
- Tanta Hospital for Mental Health — Tanta, Tanta, Qism 2, Egypt (RECRUITING)
Study contacts
- Study coordinator: Nour Elsherbeny, MSc
- Email: nelsherbeny@horus.edu.eg
- Phone: 01286911189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease