Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
Withania Somnifera root powder and placebo
Sponsors
Higher Education Commission of Pakistan (HEC) (Pakistan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients, of either sex, aged 30-65, with mild to moderate Parkinson's Disease 2. Levodopa-responsive and participants demonstrate some identifiable 'on response' as observed by investigator 3. Participants demonstrate severe motor fluctuations in spite of individually optimized levodopa treatment investigator.
Exclusion criteria
Exclusion criteria: 1. Diagnosis is unclear or a suspicion of other Parkinsonian syndromes. A group of diseases characterised by symptoms (e.g. tremour, rigidity or stiffness, slow movements and difficulty maintaining balance) common in Parkinson's disease like:- 1.1. Patients with Parkinson?s Plus syndromes 1.2. Essential tremors 1.3. Dementia with Lewy bodies 1.4. Progressive supranuclear palsy 1.5. The syndromes of olivopontocerebellar atrophy 1.6. Striatonigral degeneration 1.7. Shy-Drager 2. Undergone surgery for the treatment of PD 3. Contraindications to levodopa, or a condition which makes the treatment inadvisable 4. People with any neurological deficit that may interfere with the study assessments 5. Any sign of infection any where in the body at the time of assessment 6. Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, assessed by Modified Unified Parkinson's Disease Rating System (UPDRS) scale at baseline and 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, assessed by Modified UPDRS scale at baseline and 4 weeks. | — |
Countries
Pakistan
Outcome results
None listed