Randomised controlled trial of Withania somnifera root powder in Parkinsons Disease

ISRCTN	ISRCTN31871098
DOI	https://doi.org/10.1186/ISRCTN31871098
Protocol serial number	N/A
Sponsor	Higher Education Commission of Pakistan (HEC) (Pakistan)
Funder	Higher Education Commission of Pakistan (HEC) (Pakistan)

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

Dr Muhammad Fahad Saleem
Scientific

A-1 Pakarab Fertilizer Housing Colony
Multan
75600
Pakistan

Phone	+92 (0)32 18203914
Email	fahad.saleem@aku.edu

Primary study design	Interventional
Study design	Randomised double blind placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Efficacy, assessed by Modified Unified Parkinson's Disease Rating System (UPDRS) scale at baseline and 4 weeks.
Key secondary outcome measure(s)	Safety, assessed by Modified UPDRS scale at baseline and 4 weeks.
Completion date	30/06/2010

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

A-1 Pakarab Fertilizer Housing Colony

Multan
75600
Pakistan

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes