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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Hem

Brief 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 Summary: 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.
Sponsor: Panacea Biotec Ltd

Current Primary Outcome: Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject [ Time Frame: 14 day of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of subjects in each treatment group without recurrence of bleeding [ Time Frame: 14 days post treatment ]

Original Secondary Outcome: Same as current

Information By: Panacea Biotec Ltd

Dates:
Date Received: December 31, 2009
Date Started: March 2010
Date Completion:
Last Updated: December 4, 2012
Last Verified: December 2012