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

NCT ID: NCT07001150

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-10

Study Completion Date

2026-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

levodopa-carbidopa

Intervention Type DRUG

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.

Silymarin group

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

Group Type ACTIVE_COMPARATOR

levodopa-carbidopa

Intervention Type DRUG

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.

Silymarin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Sahar Kamal Hegazy,Head of Clinical Pharmacy Department,Faculty of Pharmacy,Tanta University

UNKNOWN

Sponsor Role collaborator

Dr. Raed Ahmed Abdel-Maboud,Lecturer of neurology,Faculty of Medicine,Tanta University

UNKNOWN

Sponsor Role collaborator

Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Nour Amr Ahmed Mosaad Elsherbeny

Teaching Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta Hospital for Mental Health

Tanta, Tanta, Qism 2, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nour Elsherbeny, MSc

Role: CONTACT

01286911189 ext. +20

Facility Contacts

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Nour A Elsherbeny, Bachelor of Pharmacy

Role: primary

01286911189

Other Identifiers

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1331999

Identifier Type: -

Identifier Source: org_study_id

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