Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised placebo-controlled trial of homoeopathic potassium phosphate 6x for mental fatigue
Acronym
Study hypothesis
That a homeopathic specific used in the treatment of attentional problems will improve performance on an attention test.
Ethics approval
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.
Study design
Randomised placebo-controlled cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please contact mb55@york.ac.uk to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Potassium phosphate
Primary outcome measures
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 trial start date
01/06/2007
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
86
Participant 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
Recruitment start date
01/06/2007
Recruitment end date
01/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
University of York (UK)
Sponsor details
University Road
York
YO10 5DD
United Kingdom
info@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health (UK) - National Coordinating Centre for Research Capacity Development, Post-Doctoral Fellowship in Complementary Medicine
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23025450
Publication citations
-
Results
Dean ME, Karsandas R, Bland JM, Gooch D, MacPherson H, Homeopathy for mental fatigue: lessons from a randomized, triple blind, placebo-controlled cross-over clinical trial., BMC Complement Altern Med, 2012, 12, 167, doi: 10.1186/1472-6882-12-167.