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Research to study the benefits of additional local antibiotic to conservative therapy for healing of painful cuts in back passage

A case control comparative study comparing the benefit of adding local and short term antibiotics to local analgesic and vasodilators in patients of anal fissures

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032801
Enrollment
216
Registered
2021-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K602- Anal fissure, unspecified

Interventions

Intervention1: Metronidazole 1% ointment in addition to 2% lignocaine gel with 0.2% nifedipine ointment: One fingertip unit of each to be applied locally in anus with applicator three times daily for

Sponsors

Dr Gopal Krishna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. patients with clinical diagnosis of anal fissure 2. lesions limited to the epithelium, 3. patients who has pain in the anal region together with ulcers 4. Ulcer in the posterior anoderm without any skin tags 5. Consenting patients willing to voluntarily take part in this study after getting detailed information

Exclusion criteria

Exclusion criteria: 1. Presumed or confirmed pregnancy 2. Lactating women 3. History of reaction or intolerance to topical agents 4. Associated co-morbidity, such as ischemic heart disease, hypertension,chronic obstructive pulmonary disease, diabetes mellitus, inflammatory bowel disease, HIV- related fissure, tuberculosis ulcer and leukemic ulcer; and associated complications warranting surgery (abscess, fistula, haemorrhoids, and cancer)

Design outcomes

Primary

MeasureTime frame
Recovery rateTimepoint: 3rd week and 6th week of treatment

Secondary

MeasureTime frame
VAS scoreTimepoint: 1st week, 3rd week and 6th week of starting treatment

Countries

India

Contacts

Public ContactDr Vivek Kumar Roy

Indira Gandhi Institute of Medical Sciences (IGIMS), Patna

roykanu23@gmail.com9801716613

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026