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Clinical Trials/CTRI/2024/08/072002
CTRI/2024/08/072002
Not yet recruiting
未知

A comparative study to evaluate the efficacy and safety of Diltiazem hydrochloride 2 percent w/w plus Lidocaine hydrochloride 2 percent w/w Gel with Lignocaine Hydrochloride Gel 2 percent w/w in anal fissure patients A Prospective Randomized Open-Label Single Centre Comparative Study - NI

Abbott India Limited0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Abbott India Limited
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Males and females with age 18 to 64 years (both inclusive) with a diagnosis of anal fissure
  • •Willing to stop all other concomitant topical preparations applied peri\-anally prior to commencing study treatment and throughout the study
  • •Subjects who understand the requirement of the study and is willing to sign and date written informed consent to participate in the study

Exclusion Criteria

  • •Subjects unwilling to have an examination of anal fissure
  • •Subjects having anal fistulas or anal fissure of various causes such as Crohn disease anal suppuration abscesses
  • •Subjects who have or have undergone the following gastrointestinal disorders or procedures Inflammatory bowel disease chronic fecal
  • •incontinence anal abscess a history of radiation therapy to the pelvis fixed anal stenosis/fibrosis
  • •Subjects with a history of neoplastic disease within 5 years
  • •Subjects with associated acute hemorrhoidal attacks
  • •Subjects having anal or perianal cancer
  • •Subjects who have had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region
  • •Subjects with a clinically significant history of renal hepatic neurological dermatological immunological major psychiatric (including drug or alcohol abusers) or hematological illness
  • •Subjects of hypertension / ischemic heart disease on oral calcium channel blockers

Outcomes

Primary Outcomes

Not specified

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