Extract of Euphorbia Prostrata in treatment of piles

Phase 4

Completed

• Conditions: Health Condition 1: null- first degree external or internal heamorrhoids

• Registration Number: CTRI/2011/12/002202
• Lead Sponsor: Panacea Biotec Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rectal bleedingTimepoint: 14 days

Secondary Outcome Measures

Name	Time	Method
rectal pain <br/ ><br> <br/ ><br>rectal discharge <br/ ><br> <br/ ><br>rectal irritation <br/ ><br> <br/ ><br>need for rescue drug <br/ ><br> <br/ ><br>Global assessments <br/ ><br>Timepoint: 2 weeks