Health Condition 1: K602- Anal fissure, unspecified
Conditions
Interventions
Intervention1: Group A (standard treatment group): They will be advised to apply locally Lidocaine 1.5 + Nefidipine 0.3% three times a day and take one sachet of Isabgol powder(6g) in 200 ml lukewar
Sponsors
Shree Dhootapapeshwar Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients of anal fissure showing a 90% reduction in the composite score in the Arsha Hitagroup as compared with the standard treatment group of Lidocaine 1.5 + Nefidipine 0.3% gel and oral Isabgol.Timepoint: Study duration for 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of lifeTimepoint: Before treatment and after 6 weeks | — |
Countries
India
Contacts
Public ContactDr Gopikrishna BJ
Sri Dharmasthala Manjunatheshwara College of Ayurveda and HospitaL
Outcome results
None listed