Clove oil to treat fissure in ano
Research type
Research Study
Full title
Feasibility Study for the acceptability of Clove oil to treat Fissure in ano
IRAS ID
252701
Contact name
Doug Speake
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
0 years, 6 months, 27 days
Research summary
Fissure in ano (FIA) is a split in the skin of the anal canal which causes severe pain and bleeding at defecation. It is common, although 50% of cases will resolve within 4-6 weeks with primary care treatment, persistence beyond 6 weeks usually prompts referral to hospital. FIA is associated with internal anal sphincter spasm, which causes severe pain and delayed healing. The rationale for all current treatments is to relax the internal anal sphincter. The only licensed treatment is 0.4% Glyceryl Trinitrate ointment (GTN). It is poorly tolerated in many patients due to side-effects of severe headache and dizziness. In secondary care, 2% diltiazem ointment has fewer side effects but is unlicensed for FIA. GTN and diltiazem achieve healing in less than 50% with a high risk of recurrence. Failure of medical treatment requires surgical intervention.\n\nClove oil has pharmacological properties (local anaesthetic, antimicrobial, vaso-dilation and smooth muscle relaxation) that would be beneficial in FIA treatment. A single study from Egypt showed that healing occurred in 60% of patients. If replicated in practice these results could offer a cost effective treatment for FIA. \n\nWe wish to assess the acceptability of clove oil treatment for FIA in UK patients. To do this we plan to offer patients clove oil ointment in outpatients at the Western General in Edinburgh when they are referred in by their GPs. Participants will be asked to self administer this for 6 weeks in the same way they would the other treatments described. They will be asked to fill in some short questionnaires taking up to 15 minutes at each visit and will receive a phone at 3 months to check there have been no further problems. This study has been funded by the Bowel Disease Research Foundation.\n\n\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0138
Date of REC Opinion
30 Nov 2020
REC opinion
Favourable Opinion