Silymarin slows Parkinson disease progression
- Trial ID
- NCT07001150
- Official Title
- Clinical Study Evaluating the Possible Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease
- Goal
- Silymarin slows Parkinson disease progression
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Tanta University
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson Disease
- Interventions
- levodopa-carbidopa, Silymarin
Summary For Families
The goal is to see whether silymarin, the active extract from milk thistle, can offer neuroprotection and help manage Parkinson's symptoms by reducing oxidative stress and inflammation that contribute to dopaminergic neuron damage. The approach adds oral silymarin to usual levodopa-carbidopa therapy; silymarin is not a dopamine replacement, it works as an antioxidant and anti-inflammatory agent, and the trial will monitor safety and any interactions with levodopa. This Phase 2 trial plans to enroll about 50 people, ages 45 to 65, who have Parkinson's and are already on dopamine replacement with Hoehn and Yahr stage 1 to 4. People who are pregnant or breastfeeding, have advanced liver disease, morbid obesity, poorly controlled diabetes, recent silymarin use, or other serious illnesses are excluded.
Locations
- Tanta Hospital for Mental Health, Tanta, Tanta, Qism 2, Egypt
Frequently Asked Questions
- What is this trial testing?
- This trial is studying levodopa-carbidopa. The goal is to see whether silymarin, the active extract from milk thistle, can offer neuroprotection and help manage Parkinson's symptoms by reducing oxidative stress and inflammation that contribute to dopaminergic neuron damage. The approach adds oral silymarin to usual levodopa-carbidopa therapy; silymarin is not a dopamine replacement, it works as an antioxidant and anti-inflammatory agent, and the trial will monitor safety and any interactions with levodopa. This Phase 2 trial plans to enroll about 50 people, ages 45 to 65, who have Parkinson's and are already on dopamine replacement with Hoehn and Yahr stage 1 to 4. People who are pregnant or breastfeeding, have advanced liver disease, morbid obesity, poorly controlled diabetes, recent silymarin use, or other serious illnesses are excluded.
- Who can participate?
- Participants must be between 45 Years and 65 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 1 year and 1 month.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.