Health Condition 1: null- Patients of Chronic Anal Fissures
Conditions
Interventions
Intervention1: Diltiazem 2 % w/w gel plus Lignocaine 2 % w/w gel: 3 applications per day for 6 weeks
Control Intervention1: Diltiazem 2 % w/w gel plus Placebo: 3 applications per day for 6 weeks
Contr
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in symptoms of pain, itching and bleeding recorded on a visual analogue scoreTimepoint: At baseline and at the end of 2, 4, 6 weeks of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment of treatment by Physician and patients as: Excellent/ Good/ Fair/ PoorTimepoint: At the end of week 6 (end of study);Healing of the anal fissure assessed clinicallyTimepoint: At the end of week 6 (end of study) | — |
Countries
India
Contacts
Public ContactDr Vijaya Jaiswal
Vice president
Outcome results
None listed