NCT01041911

To Evaluate the Dose Response of 3 Doses of Euphorbia Prostrata in Patients With First and Second Degree Hemorrhoids

Double-blind, Randomized, Placebo-controlled, Dose Response Study to Evaluate the Safety and Efficacy of Three Doses of Euphorbia Prostrata Dry Extract Tablets in Patients of Hemorrhoids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Panacea Biotec Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safe and efficacious dose of Euphorbia prostrata for control of per rectal bleeding in patients with first and second degree hemorrhoids.

Detailed description

Hemorrhoidal disease is a common entity in the general population and in clinical practice. The basic pathological factor in hemorrhoids is the dilation of the anorectal venous plexuses. In the acute bleeding of internal hemorrhoids, one of the pathogenic processes implicated is the stagnation and stasis of blood in the vascular plexuses of the prolapsed anal cushions. Euphorbia prostrata extract is found to have antihemorrhoidal activity and is useful in ameliorating signs and symptoms associated with hemorrhoids.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DRUG	Euphorbia tablets	50 mg, tablet, once daily, 14 days
DRUG	Euphorbia tablets	100 mg, tablet, once daily, 14 days
DRUG	Euphorbia tablets	200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days
DRUG	Placebo tablets	placebo, tablet, once daily, 14 days

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-10-01
• Completion: 2010-11-01
• First posted: 2010-01-01
• Last updated: 2012-12-06

Locations

6 sites across 1 country: India