Contact information
Type
Scientific
Primary contact
Mr Toni Douglas-Gooden
ORCID ID
Contact details
St. Leonard's Primary Health Centre
National Homoeopath Service
191a Kentish Town Road
London
NW5 2JU
United Kingdom
+44 (0)20 7482 0432/7301 3347
tgooden@btconnect.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC01630
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Skin and connective tissue diseases: Viral wards
Intervention
Debridement vs homeopathic treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/1999
Overall trial end date
01/01/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/1999
Recruitment end date
01/01/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St. Leonard's Primary Health Centre
London
NW5 2JU
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary