A clinical trial to compare the efficacy of Yashtimadhu Ghrita anal infiltration and Diltiazem topical application in the management of chronic anal fissure

Comparing the efficacy of Yashtimadhu Ghrita anal infiltration and Diltiazem topical application in the management of chronic anal fissure An Open label randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052302

Enrollment

100

Registered

2023-05-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K90-K95- Other diseases of the digestive system Health Condition 2: K928- Other specified diseases of the digestive system

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex aged 18-60 years. 2. Patients with chronic anal fissure greater than 6 weeks of duration. 3. Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with co-morbidities such as fistula in ano, haemorrhoids, perianal abscess, clinically evident fecal incontinence, anal stenosis/fibrosis 2. Patients with inflammatory bowel disease, tuberculosis, diabetes mellitus, anemia, malnourishment caused by systemic diseases, malignancy, HIV, STDs, hepatitis B 3. Patients with uncontrolled hypertension, clinically significant renal disease, hepatic disease, cardiovascular disease, psychiatric disease 4. Fissure associated with abscess, drug-induced fissure or fissure resulting from external trauma 5. Fissure located at lateral locations and multiple fissures 6. Patients on medications hampering wound healing (corticosteroids, NSAIDs, anti-convulsants, anticoagulants, immunosuppressive agents etc.) 7. Patients using oral calcium channel blockers 8. Patients with frequent h/o headache 9. Active substance abuse 10. Known hypersensitivity to either of the trial interventions 11. Pregnant and lactating women 12.Patients who have been using either of the trial interventions prior to 30 days of randomization

Design outcomes

Primary

Measure	Time frame
Proportion of participants having complete healing of the chronic anal fissureTimepoint: 30 days	—

Secondary

Measure	Time frame
Incidence of adverse events during the study periodTimepoint: 30 days;Pain during defecationTimepoint: day 8, 15, 22, 30;Proportion of participants having complete healing of the chronic anal fissureTimepoint: after one week ;Recurrence of anal fissure after complete healingTimepoint: day 60, day 90 and day 180;Time to cessation of bleedingTimepoint: day 8, 15, 22 & 30	—

Countries

India

Contacts

Public ContactDr Hemanta Panigrahi

CARI

drhemanta71@gmail.com9968074400

Outcome results