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Clinical Trials/CTRI/2008/091/000280
CTRI/2008/091/000280CompletedPhase 4

A double blind comparative randomized study evaluating the efficacy and safety of combined application of topical diltiazem and lignocaine as compared to topical dilitazem and lignocaine alone in the management of anal fissures

Troikaa Pharmaceuticals Limited0 sites75 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
75

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • 1.Adult patients aged between 18 - 60 years.
  • 2.Patients with a diagnosis of chronic anal fissure
  • 3.Patients with symptoms persisting after 2 weeks of standard management (diet, laxatives, Sitz-baths)

Exclusion Criteria

  • 1.Patients having anal fistulas or anal fissure of various causes such as Crohn disease, anal suppuration, abscesses,
  • 2.Patients with associated acute haemorrhoidal attacks
  • 3.Patients having anal or perianal cancer
  • 4.Patients who have been surgically treated previously
  • 5.Pregnant women
  • 6.Patients of hypertension / IHD on oral CCBs.
  • 7.Known hypersensitivity to either dilitiazem or lignocaine
  • 8.Pregnant women /lactating mother
  • 9.Patients talking CCB, Nitrates, vasodilator
  • 10.Patients with HIV infection

Investigators

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