Parkinson Disease
Conditions
Keywords
Metformin, Parkinson disease
Brief summary
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.
Detailed 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.
Interventions
DRUGMetformin
Metformin's chemical name is 1,1-Dimethylbiguanide, a molecular formula of C4H11N5. Beyond its well established antihyperglycemic impact, metformin demonstrated anti-oxidant and anti-inflammatory activities contributing its potential benefits in conditions associated with inflammation and oxidative stress. Furthermore, metformin rapidly crosses the blood brain barrier and disperses into several brain regions presenting an ideal therapeutic option for the treatment of PD.
OTHERplacebo
placebo of tab. Metformin of same shape
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| motor aspects of daily living | 8 weeks | motor aspects of daily living in MDS-UPDRS rating scale (Movement Disorder Society- sponsored revision of the Unified Parkinson's Disease Rating Scale). The score of Part 2 of this scale i.e. motor experiences of daily living is 13. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. Plasma Malondealdehyde (MDA) level in micromole/litre. 2. Erythrocyte Glutathione (GSH) level in mg/ml. | 8 weeks | Malondealdehyde is oxidative stress marker. Glutathione is anti-oxidant. |
| 1. Erythrocyte glutathione level in mg/ml 2. Erythrocyte Glutathione (GSH) level in mg/ml. | 8 weeks | Glutathione is an anti-oxidant Glutathione is anti-oxidant. |
| Comparison of adverse effects in percentage | 8 weeks | Adverse effects in Metformin treated and placebo treated patients |
Countries
Bangladesh
Outcome results
None listed