The efficacy of homoeopathic potassium phosphate for mental fatigue

ISRCTN	ISRCTN16521161
DOI	https://doi.org/10.1186/ISRCTN16521161
Secondary identifying numbers	N/A

Submission date: 25/06/2009
Registration date: 01/09/2009
Last edited: 23/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Emmans Dean
Scientific

Department of Health Sciences
University of York
Seebohm Rowntree Building
University Road
York
YO10 5DD
United Kingdom

Study information

Study design	Randomised placebo-controlled cross-over trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please contact mb55@york.ac.uk to request a patient information sheet
Scientific title	A randomised placebo-controlled trial of homoeopathic potassium phosphate 6x for mental fatigue
Study objectives	That a homeopathic specific used in the treatment of attentional problems will improve performance on an attention test.
Ethics approval(s)	Health Services Research Governance Committee (HSRGC) of the University of York approved on the 13th March 2007. As this trial did not involve any patients, it did not have to go through the National Health Service ethics system.
Health condition(s) or problem(s) studied	Mental fatigue
Intervention	Intervention: a single homeopathic dose of 0.6 g lactose powder, medicated with Kali-phos 6x (in 90% ethanol/water solution) Control: identical placebo consisting of 0.6 g lactose powder, treated with unmedicated 90% ethanol/water solution Treatment consisted of a single dose, crossed over at the same time on the same day one week later. There was no follow-up.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Potassium phosphate
Primary outcome measure	Accuracy on the Stroop-colour-word test of executive function, measured 10 minutes after medication (at the same time on the same day one week apart).
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/06/2007
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	86
Key inclusion criteria	1. Healthy staff and student volunteers, aged 19 to 62 years, either sex 2. Recruited from within the University of York 3. Reporting fatigue from mental work
Key exclusion criteria	1. Current use of homeopathy for any condition 2. Current prescribed stimulant medication 3. Use of self-prescribed stimulants (e.g. caffeine-based products) during the study 4. Chronic fatigue 5. Unable to communicate in English
Date of first enrolment	01/06/2007
Date of final enrolment	01/09/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Health Sciences

York
YO10 5DD
United Kingdom

Sponsor information

University of York (UK)
University/education

University Road
York
YO10 5DD
England
United Kingdom

Email	info@york.ac.uk
Website	http://www.york.ac.uk/
"ROR"	https://ror.org/04m01e293

Funders

Funder type

Government

Department of Health (UK) - National Coordinating Centre for Research Capacity Development, Post-Doctoral Fellowship in Complementary Medicine

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No