Randomised controlled trial of Withania somnifera root powder in Parkinsons Disease
| ISRCTN | ISRCTN31871098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31871098 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/02/2010
- Registration date
- 07/06/2010
- Last edited
- 07/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Muhammad Fahad Saleem
Scientific
Scientific
A-1 Pakarab Fertilizer Housing Colony
Multan
75600
Pakistan
| Phone | +92 (0)32 18203914 |
|---|---|
| fahad.saleem@aku.edu |
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please email fahad.saleem@aku.edu to request a patient information sheet. |
| Scientific title | Randomised placebo-controlled trial of adjuvant therapy with Withania somnifera in Parkinsons Disease |
| Study acronym | WiS-PD |
| Study objectives | 3 grams per day of Withania somnifera root powder, as an adjuvant therapy to standard care, would improve Unified Parkinson's Disease Rating System (UPDRS) score by more than 10 points in patients with Parkinsons disease compared to placebo. |
| Ethics approval(s) | Ethical Review Committee of Aga Khan University Hospital, Karachi approved on the 28th of August 2009 (ref: 1266/CHS/ERC-09) |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Withania Somnifera root powder and placebo |
| Intervention type | Other |
| Primary outcome measure | Efficacy, assessed by Modified Unified Parkinson's Disease Rating System (UPDRS) scale at baseline and 4 weeks. |
| Secondary outcome measures | Safety, assessed by Modified UPDRS scale at baseline and 4 weeks. |
| Overall study start date | 01/04/2010 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key 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. |
| Key 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 Parkinsons 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 |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
A-1 Pakarab Fertilizer Housing Colony
Multan
75600
Pakistan
75600
Pakistan
Sponsor information
Higher Education Commission of Pakistan (HEC) (Pakistan)
Government
Government
c/o Mr. Abid Ali Gohar (Director Research and Development)
Islamabad
75600
Pakistan
| Phone | +92 (0)51 90401910 |
|---|---|
| aagohar@hec.gov.pk | |
| Website | http://www.hec.gov.pk |
"ROR" |
https://ror.org/038y3sz68 |
Funders
Funder type
Government
Higher Education Commission of Pakistan (HEC) (Pakistan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
