Observational Study Evaluating Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Treating Acute Uncomplicated Hemorrhoidal Disease

What this Trial Is About

This research aims to evaluate the effectiveness of a topical cream containing nifedipine 0.3% and lidocaine 1.5% for treating patients with uncomplicated acute hemorrhoidal disease. The main question is whether this treatment can reduce symptoms in patients with this condition. The study is observational and focuses on patients already using this cream as part of their regular care. Participants will apply the topical nifedipine 0.3% plus lidocaine 1.5% cream both rectally and perianally twice daily for at least 21 days. The study involves four assessments over about 30 days a baseline visit within five days of starting treatment, a telephone contact at day 10, an in-person visit at day 21, and a final telephone contact at day 30. The study plans to enroll 80 patients. During the study, participants will complete symptom questionnaires including the Hemorrhoidal Disease Symptom Score HDSS and assessments of quality of life, pain, and hemorrhoidal prolapse. Data will be collected and analyzed to understand symptom changes and treatment impact. The primary outcome is the change in HDSS over 30 days. The study includes monitoring of symptoms and quality of life throughout the 30-day observation period.

Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease