levodopa-carbidopa for Parkinson's (NCT07001150)
Protect dopamine producing brain cells
- Trial ID
- NCT07001150
- Official Title
- Clinical Study Evaluating the Possible Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease
- Goal
- Protect dopamine producing brain cells
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Tanta University
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson Disease
- Interventions
- levodopa-carbidopa, Silymarin
Summary For Families
Researchers are testing whether silymarin, a plant-based antioxidant compound, can protect the dopamine-producing brain cells that are lost in Parkinson's and help manage symptoms. Participants will take silymarin while staying on their usual dopamine replacement treatment, such as levodopa-carbidopa, so investigators can see if adding this antioxidant helps symptoms or slows damage. The trial is looking for people aged 45 to 65 who have Parkinson's and are already on dopamine replacement therapy, in stages 1 to 4 on a common Parkinson's stage scale. People who are pregnant or breastfeeding, have advanced liver disease, a very high body mass index, serious uncontrolled illness, or who recently used silymarin are not eligible.
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. Researchers are testing whether silymarin, a plant-based antioxidant compound, can protect the dopamine-producing brain cells that are lost in Parkinson's and help manage symptoms. Participants will take silymarin while staying on their usual dopamine replacement treatment, such as levodopa-carbidopa, so investigators can see if adding this antioxidant helps symptoms or slows damage. The trial is looking for people aged 45 to 65 who have Parkinson's and are already on dopamine replacement therapy, in stages 1 to 4 on a common Parkinson's stage scale. People who are pregnant or breastfeeding, have advanced liver disease, a very high body mass index, serious uncontrolled illness, or who recently used silymarin are not eligible.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 1 year and 1 month.
- 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.
- 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.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.