ISRCTN ISRCTN16521161
DOI https://doi.org/10.1186/ISRCTN16521161
Protocol serial number N/A
Sponsor University of York (UK)
Funder Department of Health (UK) - National Coordinating Centre for Research Capacity Development, Post-Doctoral Fellowship in Complementary Medicine
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

Primary study designInterventional
Study designRandomised placebo-controlled cross-over trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA randomised placebo-controlled trial of homoeopathic potassium phosphate 6x for mental fatigue
Study objectivesThat 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) studiedMental fatigue
InterventionIntervention: 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Potassium phosphate
Primary outcome measure(s)

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).

Key secondary outcome measure(s)

No secondary outcome measures

Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration86
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2007
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Health Sciences
York
YO10 5DD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes