A double blind, randomised, parallel group study evaluating the efficacy of a homeopathic remedy in asthma
ISRCTN | ISRCTN56657172 |
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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
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 |
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GL3@soton.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | The 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) studied | Respiratory tract diseases: Asthma |
Intervention | Participants were randomised to receive oral homeopathic immunotherapy or identical placebo |
Intervention type | Other |
Primary outcome measure | Clinical 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 measures | Not provided at time of registration |
Overall study start date | 01/04/1996 |
Completion date | 01/01/1999 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 55 Years |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | Aged 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 criteria | Previous 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 enrolment | 01/04/1996 |
Date of final enrolment | 01/01/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Southampton
Southampton
SO14 0YG
United Kingdom
SO14 0YG
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 02/03/2002 | Yes | No |