Evaluation of specific and non-specific effects in homoeopathy. Feasibility study for a randomised trial

ISRCTN ISRCTN17287738
DOI https://doi.org/10.1186/ISRCTN17287738
Protocol serial number N0257012231
Sponsor Department of Health (UK)
Funder Parkside Health NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
19/10/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Fisher
Scientific

Royal London Homoeopathic Hospital
60 Great Ormond Street
London
WC1N 3HR
United Kingdom

Phone +44 (0)20 7833 7223
Email pfisher@gn.apc.org

Study information

Primary study designInterventional
Study designRandomised 4-arm 2-arm double blind placebo controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesPilot study to determine acceptability to patients and staff and whether design produces interpretable data. Questions for definitive study: Is homoeopathic consultation and placebo treatment more effective than no treatment? Is homoeopathic consultation and verum treatment more effective than homoeopathic consultation and placebo treatment? Is unblinded homoeopathic treatment more effective than blinded?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAtopic dermatitis
InterventionRandomised placebo controlled clinical trial with double-blind comparison.
Intervention typeOther
Primary outcome measure(s)

1. Dermatology Life Quality Index questionnaire
2. Symptom diary
3. Treatment diary

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/05/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration100
Key inclusion criteria100 Patients referred to the Royal London Homoeopathic Hospital with a diagnosis of atopic eczema.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/04/1998
Date of final enrolment31/05/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Royal London Homoeopathic Hospital
London
WC1N 3HR
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 01/10/2006 Yes No