Health Condition 1: K629- Disease of anus and rectum, unspecified
Conditions
Interventions
Intervention1: CremaGel-H: FDC of Sucralfate 7% w/w, Metronidazole 1% w/w, and Lignocaine Hydrochloride 4% w/w
Dosage: OD
Route of Administration: Topical Application
Duration of Therapy: 06 weeks
Co
Sponsors
Dr Niranjan Agarwal
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients above 18 up to 64 years (both inclusive) 2. Patients who are undergoing surgery of hemorrhoids, fistulae, and / or anal fissures and are willing to take CremaGel-H for their postoperative symptoms 3. Patients willing to comply with study procedures and requirements 4. Patients willing to sign and date written informed consent form (ICF) to participate in the study
Exclusion criteria
Exclusion criteria: 1. History of inflammatory bowel disease, multiple fistulas, perianal dermatitis, proctitis, pulmonary or cardiovascular complications, or poorly controlled diabetes mellitus 2. Anal fistulas or anal fissure due to other causes such as Crohn disease, anal suppuration, and abscesses 3. Recent history ( 4. Diagnosis of active cancer, severe anemia, hypoalbuminemia, or immunocompromise 5. Past history of hypersensitivity to any of the ingredients of the study product, including Metronidazole, Lignocaine Hydrochloride, Sucralfate, or any other ingredient in the formulation 6. Patients on Class I anti-arrhythmic drugs or anticoagulant treatment as the toxic effects are additive and generally synergistic 7. Any past or present conditions / diseases that Investigator considers inappropriate for a patient to participate in the study 8. Patients who are unwilling to have an examination of anal wounds 9. Pregnant and lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with minimal clinically important difference (MCID) at 3 and 6 weeks after surgery where MCID is defined as reduction in 10 points on 100 mm VAS scale at 3 and 6 weeks after surgery from the baseline score 2. 2. Mean reduction in anal pain (on 100 mm VAS score) from baselineTimepoint: at baseline, Week 3 and Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean reduction in â?¢ Burning on a 4 point scale ranging from score 0 (no symptoms) to score 3 (severe intensity symptoms)Timepoint: from baseline to 3 and 6 weeks after surgery;Mean reduction in â?¢ Itching on a 5-point scale ranging from score 1 (not present) to score 5 (unbearable)Timepoint: from baseline to 3 and 6 weeks after surgery;Mean reduction in Bleeding score on a 5 point scale ranging from 1 episode per 2 weeks to 5 bleeding episodes per weekTimepoint: from baseline to 3 and 6 weeks after surgery;Proportion of patients with complete wound healingTimepoint: at 3 and 6 weeks after surgery | — |
Countries
India
Contacts
Public ContactMr Hitesh Thakur
Salasar Nursing Home
Outcome results
None listed