Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Active, not recruiting; Phase 3

Conditions: Parkinson Disease

Treatments: Drug: Metformin; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07055958

5246

Details and patient eligibility

About

The goal of this clinical trial is to learn that metformin has effect on motor aspects of daily living and oxidative stress in levodopa treated Parkinson disease patients. Researcher will compare drug metformin to a placebo. Participants will take metformin or placebo for 8 weeks.

Full description

This clinical trial is an effort to explore whether administration of metformin has effect on motor aspects of daily living and oxidative stress in levodopa treated Parkinson's disease patients. After completion of necessary formalities, each participant will be assessed by translated and validated Bangla version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part questionnaire and malondialdehyde (MDA) and glutathione (GSH) will be measured at baseline and after 8 weeks.

Enrollment: 74 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed mild to moderate PD patients taking Levodopa
• Age 18 years and older
• Sex : Any

Exclusion criteria

• Secondary causes of Parkinsonism
• Prior stereotactic surgery for PD
• Suffering from active malignancy
• Known hypersensitivity to metformin
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Metformin- Patients receiving Levodopa with Metformin

Experimental group

Description:

Dosage form- Tab. Metformin 500 mg, Frequency - once daily, Duration - 8 weeks

Treatment:

Drug: Metformin

Control - Patients receiving Levodopa with Placebo

Placebo Comparator group

Description:

placebo of Tab. Metformin 500 mg, frequency- once daily, duration- 8 weeks

Treatment:

Other: placebo