Not Yet RecruitingPhase 2ACTRN12625001130459

The effect of topical flavanoid cream on post-operative excisional haemorrhoidectomy pain; a randomised controlled trial

The effectiveness of Topical Micronized Purified Flavonoid Fraction Post Excisional Haemorrhoidectomy on Pain: A Double-Blinded Randomised Controlled Trial in Adult patients.


Sponsor

University of Auckland

Enrollment

120 participants

Start Date

Feb 1, 2026

Study Type

Interventional

Conditions

Summary

The purpose of this trial is test whether a new medication containing a plant based product MPPF, will reduce the amount of pain patients experience following an excisional haemorrhoidectomy. Evidence suggests there may be a reduction of pain following administration of oral MPPF, however there is no evidence to support the use of a topical formulation. We hypothesize that our cream will reduce the amount of pain patients report following excision of haemorrhoids, adding to a growing number of analgesic options for a very common problem seen worldwide.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Adult patients 18 years and over undergoing excisional haemorrhoidectomy of any type (open, closed)
  • Grade III or IV haemorrhoids
  • Willing and able to provide informed consent
  • Able to apply topical treatments independently

Exclusion Criteria7

  • Patient’s <18 years
  • Haemorrhoids grade I or II
  • Concurrent perianal pathology – fissure, fistulas, ulcers etc
  • Known allergy or adverse drug reaction to metronidazole or lignocaine
  • Pregnant or breastfeeding women
  • Patients with history of chronic pain
  • Patients unable to consent due to cognitive impairment or language barrier where an interpreter is unavailable

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Interventions

Intervention drug is a topical cream composed of 10% metronidazole (antibiotic), 4% lignocaine (local anaesthetic), and 5% micronized purified flavanoid fraction (MPFF). This will be taken for 1 week,

Intervention drug is a topical cream composed of 10% metronidazole (antibiotic), 4% lignocaine (local anaesthetic), and 5% micronized purified flavanoid fraction (MPFF). This will be taken for 1 week, three times per day. Applied morning following surgery. The tubes will be collected and weighed to measure adherence at follow up. The application of a topical cream composed of 10% metronidazole (antibiotic), 4% lignocaine


Locations(1)

Auckland, New Zealand

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