A double blind, randomised, parallel group study evaluating the efficacy of a homeopathic remedy in asthma

ISRCTN ISRCTN56657172
DOI https://doi.org/10.1186/ISRCTN56657172
Secondary identifying numbers R/35/9.95/Holg
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
29/11/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr George Lewith
Scientific

University of Southampton
Complementary Medicine Research Unit
Mailpoint OPH
Royal South Hants Hospital
Britons Terrace
Southampton
SO14 0YG
United Kingdom

Phone +44 023 8082 5246
Email GL3@soton.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesThe use of homoeopathy in the treatment of allergic disease remains controversial. Two recent reviews concluded that, of the numerous trials investigating homoeopathy, many were methodologically unsound. Numerous calls have been made for better designed and conducted studies in homoeopathy and other complementary therapies. Two such studies investigating the role of homoeopathy in patients with allergic rhinitis and asthma have been performed in Glasgow. Both of these randomised controlled trials reported a significant effect in favour of homoeopathy. This grant proposal aims to replicate the Glasgow findings in their asthma study using an identical treatment in a larger number of patients, and with greater statistical power. The protocol has been developed by extensive consultation within the research homoeopathic community, and will assess two main outcome measures, namely forced expiratory volume in one second FEV1) and the percentage of asthma problem-free days (%PFD). In addition it will employ a number of secondary outcomes to assess well being with respect to asthma. It is anticipated that this trial will provide guidance on whether homoeopathy should be available as a new service provision to purchasers within the NHS, and as such will have significant resource implications for the NHS.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRespiratory tract diseases: Asthma
InterventionParticipants were randomised to receive oral homeopathic immunotherapy or identical placebo
Intervention typeOther
Primary outcome measureClinical based assessments: forced expiratory volume in one second (FEV1), quality of life and mood. Diary based assessments: morning and evening peak expiratory flow, visual analogue scale of severity of asthma, quality of life and daily mood
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1996
Completion date01/01/1999

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit55 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaAged 18-55, positive skin prick test to house dust mite, re-diagnosed asthma in response to bronchodilators and activity limited by asthma during pre-treatment baseline period
Key exclusion criteriaPrevious drug trial within 30 days, previous treatment with homeopathic immunotherapy, pregnancy, respiratory tract infection within 3 weeks of recruitment or change in asthma medication in the 2 weeks prior to entry
Date of first enrolment01/04/1996
Date of final enrolment01/01/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Southampton
Southampton
SO14 0YG
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South West

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 02/03/2002 Yes No