Healing the Sole: A research project to investigate the effectiveness and benefits of individual homoeopathic treatment and chiropody 'debridement' for adults with chronic verrucas
ISRCTN | ISRCTN11683925 |
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DOI | https://doi.org/10.1186/ISRCTN11683925 |
Secondary identifying numbers | RDC01630 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 11/04/2016
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Toni Douglas-Gooden
Scientific
Scientific
St. Leonard's Primary Health Centre
National Homoeopath Service
191a Kentish Town Road
London
NW5 2JU
United Kingdom
Phone | +44 (0)20 7482 0432/7301 3347 |
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tgooden@btconnect.com |
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 | Healing the Sole: A research project to investigate the effectiveness and benefits of individual homoeopathic treatment and chiropody 'debridement' for adults with chronic verrucas |
Study objectives | The objective of this research project is to investigate whether 'individual' homeopathic treatment is effective (by effective we mean has the verruca been cured or reduced in size) and beneficial (by beneficial we mean do the people in the study 'feel better in themselves'), compared to using 'Debridement' (the removal of the superficial callous that forms on the surface of the verruca) to individual adult patients with chronic veruccae, within a busy inner-city, multi-cultural foot-health (chiropody) clinic. The study will further investigate the clinical significant findings from the previous nine months of the study, based at St Leonards (funded by the Blackie Foundation). Was the 75% overall improvement in patient's veruccae achieved in the pilot study, attributed to homeopathic remedies or the therapeutic effect of the consultation? Was this improvement due to a combination of 'self-selection' and the 'natural history' of the condition. To find answers to these questions is the reason why this larger randomised trial using the two 'Debridement' active and placebo groups is proposed. This study will aim to provide the NHS and other foot health departments with more data on the treatments of veruccae. Utilising the outcomes from the study, it is hoped that foot health departments may be able to offer a pain free, holistic and more cost effective treatment for verrucae. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Skin and connective tissue diseases: Viral wards |
Intervention | Debridement vs homeopathic treatment |
Intervention type | Other |
Primary outcome measure | 1. The cure or decrease in size of the verrucae (via photographs from a special grid film camera) 2. The quality of life of the patient - do the patients feel better in themselves? (via SF36 life-style questionnaire) |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/09/1999 |
Completion date | 01/01/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | Not provided at time of registration |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/09/1999 |
Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St. Leonard's Primary Health Centre
London
NW5 2JU
United Kingdom
NW5 2JU
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 London (UK)
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 |
Editorial Notes
11/04/2016: No publications found, verifying study status with principal investigator.