se of Arshkeyt in Anal Fissure

Phase 4

Completed

• Conditions: Health Condition 1: K602- Anal fissure, unspecified

• Registration Number: CTRI/2020/11/029129
• Lead Sponsor: Solumiks Herbaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-14
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

2.Patients with a confirmed diagnosis of anal fissure.

3.Patients with previous history of no treatment or only

conservative treatment, consisting of sitz bath and/or Isabgol

powder and/or high fibre diet in the last 1 month.

4. Patients with a composite score of > 4 at baseline visit.

Exclusion Criteria

1. Patients having anal fistulas or anal fissure of various

causes such as Crohn’s disease, anal suppuration,

abscesses (Secondary underlying causes).

2. Patients having anal or perianal malignancy.

3. Patients with diagnosis of any illness (other than anal

fissure) with presentation of per-anal bleeding

4. Patients with history of > 3 recurrences of anal fissure

post medical or surgical intervention.

5. Patients on oral calcium channel blockers or vasodilators

like minoxidil, hydralazine or alprostadil.

6. Patients who have a history of topical therapy with

nitroglycerine/ lignocaine/ steroids/ calcium channel

blockers in the past one month.

7. Patients who are pregnant or lactating.

8. Patients with history of life threatening cardiovascular

and /or neurological event in the past one year.

9. Patients with auto-immune disease, uncontrolled

hypertension, uncontrolled diabetes mellitus(requiring

change in antidiabetic therapy every 3 months) and

chronic severe respiratory disease.

10. Patients with documented evidence of renal function tests

> 1 and a half times of normal reference range at baseline

visit.

11. Patients withdocumented evidence of liver function tests

> 2 and a half times of normal reference range at baseline

visit.

12. Patients with history of HIV/HBV/HCV infection in the

past.

13. Patients on herbaceutical medication since the last 3

months.

14. Patient allergic to any of the ingredients of trial drug or

the comparator drug.

15. Patients currently participating in another clinical trial for

any indication or has participated in any clinical trial in

the last 30 days.

16. Patient not willing to sign on the informed consent

document or not willing to come for follow-up visits.

Study & Design

• Study Type: Interventional
• Study Design: Not specified