Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Topical application of Jatyadi Ghrita, Ashwini Mudra and topical nifedipine 0.3% and lidocaine 1.5% cream: Patients in group A will be treated with topical Jatyadi Ghrita ointment twice
Sponsors
All India Institute of Medical Sciences Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to participate. 2. The age should be 16 to 60 years 3. Gender will be both male and female 4. Patients with a diagnosis of chronic anal fissure who had symptoms for more than 6 weeks. 5. Patients whose symptoms are not resolved by stool softeners, high fiber diet, warm sitz bath, etc. 6. A physical examination will show an anal ulcer with indurated edges and/or skin tag. 7. The VAS score should be between 3 to 7.
Exclusion criteria
Exclusion criteria: 1. History of reaction to topical agents. 2. Patients whose symptoms resolved within 6 weeks by stool softeners, high fiber diet, and warm sitz bath. 3. Patient with multiple anal fissures. 4. Patients suffering from severe anemia, carcinoma, chrons disease, ulcerative colitis, diabetes mellitus, hypertension, and HIV. 5. Pregnant women 6. Tuberculous ulcers and leukemic ulcers should be excluded. 7. Patient with perianal abscess, anal fistula, and third and fourth-degree hemorrhoids. 8. Chronic anal fissure patients with severe pain (VAS more than 7) and excessive bleeding per anum should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in REALISE score at baseline, after 2 weeks, 4 weeks, and 8 weeks of treatmentTimepoint: Baseline, 2 weeks, 4 weeks and 8 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Healing period of chronic anal fissure. Adverse events during treatment. Timepoint: Baseline, 2 weeks, 4 weeks and 8 weeks of treatment. | — |
Countries
India
Contacts
Public ContactAjit Kumar Pradhan
All India Institute of Medical Sciences Bhubaneswar
Outcome results
None listed