A Study To Compare The Efficacy And Safety Of Arsha Hita In The Treatment Of Anal Fissure
- Conditions
- Health Condition 1: K602- Anal fissure, unspecified
- Registration Number
- CTRI/2020/02/023229
- Lead Sponsor
- Shree Dhootapapeshwar Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult patients aged between 18 - 60 years of either sex.
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.
1.Patients having anal fistulas or anal fissure of various causes such as Crohnâ??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 rangeat 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method