Condition category
Signs and Symptoms
Date applied
25/06/2009
Date assigned
01/09/2009
Last edited
23/05/2013
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 Michael Emmans Dean

ORCID ID

Contact details

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

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

http://www.york.ac.uk/

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

  1. 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.

Additional files

Editorial Notes