Randomised controlled trial of Withania somnifera root powder in Parkinson?s Disease
- Conditions
- Parkinson's diseaseNervous System Diseases
- Registration Number
- ISRCTN31871098
- Lead Sponsor
- Higher Education Commission of Pakistan (HEC) (Pakistan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy, assessed by Modified Unified Parkinson's Disease Rating System (UPDRS) scale at baseline and 4 weeks.
- Secondary Outcome Measures
Name Time Method Safety, assessed by Modified UPDRS scale at baseline and 4 weeks.