Health Condition 1: K601- Chronic anal fissure
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: a. Patients of either sex with chronic anal fissure greater than 6 weeks of duration b. Patients between the age group of 16 - 65 years c. Patients capable of and freely willing to provide written informed consent prior to participating in the study and comply with the study protocol requirements. d. Patients willing to discontinue or avoid nonprescription and prescription medicine (apart from conservative care such as diet, adequate fluid, and sitz baths) for the treatment of Chronic Anal Fissure for the duration of the study.
Exclusion criteria
Exclusion criteria: a. Patients with other co-morbidities like uncontrolled Diabetes mellitus, anemia, malnourishment caused by systemic diseases, fistula in ano, haemorrhoids, perianal abscess, clinically evident fecal incontinence & anal stenosis/fibrosis, inflammatory bowel disease, tuberculous ulcer, malignancies and HIV b. Patients with uncontrolled hypertension, clinically significant renal disease, hepatic disease and cardiovascular disease, psychological diseases (anxiety, depression etc.), active substance abuse and patients on medications hampering wound healing. c. Fissure associated with abscess, Drug induced fissures or fissure resulting from external trauma d. Fissures located at lateral locations and multiple fissures e. Patients using oral calcium channel blockers f. Known sensitivity to intervention drug or calcium channel blockers g. Patients with frequent h/o headaches and who are receiving any steroids, NSAIDs, etc., either for fissure or any unrelated disease condition. h. Pregnant and lactating women i. Patients who have been using either of the trial interventions within 30 days of randomization of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete healing of the anal fissureTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete healing of the anal fissure after 7 days & 14 days. 2. Pain during defecation 3. Time to cessation of bleeding 4. Recurrence 5. Adverse eventsTimepoint: 1. 8th & 15th day 2.3. - 8th, 15th , 22nd & 30th day 4. 5 months 5. 30 days | — |
Countries
India
Contacts
Public ContactDr Pratap Shankar K M
National Ayurveda Research Institute for Panchakarma
Outcome results
None listed