Condition category
Nervous System Diseases
Date applied
16/02/2010
Date assigned
07/06/2010
Last edited
07/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Muhammad Fahad Saleem

ORCID ID

Contact details

A-1 Pakarab Fertilizer Housing Colony
Multan
75600
Pakistan
+92 (0)32 18203914
fahad.saleem@aku.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised placebo-controlled trial of adjuvant therapy with Withania somnifera in Parkinson’s Disease

Acronym

WiS-PD

Study hypothesis

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 Parkinson’s disease compared to placebo.

Ethics approval

Ethical Review Committee of Aga Khan University Hospital, Karachi approved on the 28th of August 2009 (ref: 1266/CHS/ERC-09)

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please email fahad.saleem@aku.edu to request a patient information sheet.

Condition

Parkinson's disease

Intervention

Withania Somnifera root powder and placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2010

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

01/04/2010

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Pakistan

Trial participating centre

A-1 Pakarab Fertilizer Housing Colony
Multan
75600
Pakistan

Sponsor information

Organisation

Higher Education Commission of Pakistan (HEC) (Pakistan)

Sponsor details

c/o Mr. Abid Ali Gohar (Director Research and Development)
Islamabad
75600
Pakistan
+92 (0)51 90401910
aagohar@hec.gov.pk

Sponsor type

Government

Website

http://www.hec.gov.pk

Funders

Funder type

Government

Funder name

Higher Education Commission of Pakistan (HEC) (Pakistan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes