Clinical Trial

A Phase III Clinical Trial Evaluating the Efficacy and Safety of TriThien Duoc Capsules in Grade II Internal Haemorrhoids Patients With Bleeding Compared to Diosmin.

Completed Phase 3
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Summary
A Phase III, randomized, double-blind, placebo-controlled clinical trial has been conducted to evaluate the efficacy and safety of Trĩ Thiên Dược capsules in people with grade II internal hemorrhoids with bleeding. This study aims to further assess the therapeutic effects and potential adverse effects of Trĩ Thiên Dược, a herbal formulation containing Portulaca Oleracea L. (purslane) and Amaranthus Spinosus L. (spiny amaranth), in comparison to Diosmin (Daflon).Participants will undergo a 5-week study period and will be randomly assigned (1:1 ratio) into one of two groups:Research Group: Participants receiving Trĩ Thiên Dược tablets.Control Group: Participants receiving Daflon (Diosmin).The treatment regimen will last for 28 days, followed by an additional follow-up period extending to day 35 after the initial treatment.
Trial Details
NCT Number NCT07369635
Lead Sponsor Hanoi Medical University
Conditions Grade II Internal Hemorrhoids With Bleeding
Enrollment 172 participants
Start Date 2020-07-10
Primary Completion 2020-09-29 (estimated)
Study Completion 2020-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-27