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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN31871098
Date of registration: 07/06/2010
Primary sponsor: Higher Education Commission of Pakistan (HEC) (Pakistan)
Public title: Randomised controlled trial of Withania somnifera root powder in Parkinson?s Disease WiS-PD
Scientific title: Randomised placebo-controlled trial of adjuvant therapy with Withania somnifera in Parkinson?s Disease
Date of first enrolment: Apr 1 2010
Target sample size: 30
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN31871098
Study type:  Interventional
Study design:  Randomised double blind placebo controlled trial  
Countries of recruitment
Contacts
Key inclusion & exclusion 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: 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


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Parkinson's disease
Intervention(s)
Withania Somnifera root powder and placebo
Primary Outcome(s)
Efficacy, assessed by Modified Unified Parkinson's Disease Rating System (UPDRS) scale at baseline and 4 weeks.
Secondary Outcome(s)
Safety, assessed by Modified UPDRS scale at baseline and 4 weeks.
Secondary ID(s)
N/A
Source(s) of Monetary Support
Higher Education Commission of Pakistan (HEC) (Pakistan)
Secondary Sponsor(s)
N/A
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