Health Condition 1: null- first degree external or internal heamorrhoids
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with diagnosis of acute uncomplicated first degree external or internal hemorrhoids with active bleeding without infection and prolapse. Provided written informed consent.
Exclusion criteria
Exclusion criteria: Presence of infection of anorectal region. Presence of other rectal pathology like anal fissure, rectal prolapse, ischiorectal abscess, anorectal fistula, or rectal polyp. Subjects with known hepatic or kidney diseases. Patients with known hypersensitivity to ingredients of study or comparator treatments Clinically significant co-morbid condition other than bleeding piles that could directly affect the efficacy & tolerability outcome of the study. Donated blood or plasma or participated in another clinical study with an investigational agent within 4 weeks preceding to enrollment. H/O drug/alcohol abuse. Pregnant and lactating women. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rectal bleedingTimepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| rectal pain rectal discharge rectal irritation need for rescue drug Global assessments Timepoint: 2 weeks | — |
Countries
India
Contacts
Panacea Biotec Ltd.