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.

Overview

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.

Study Design: This study is a randomized, open-label, placebo-controlled trial evaluating the efficacy of Diosmin (Daflon) in people with grade II internal hemorrhoids with bleeding. Participants are randomly assigned in a 1:1 ratio to receive either Tri Thien Duoc pills or Diosmin (Daflon). Participants: A total of 172 participants with grade II internal hemorrhoids with bleeding were enrolled in the study and allocated as follows: Intervention Group: 86 participants received Tri Thien Duoc pills at a dosage of 8 capsules per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment. Control Group: 86 participants received Diosmin (Daflon) at a dosage of 4 pills per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment. Study Procedures: All participants in this Phase III study adhered to the dietary and lifestyle recommendations outlined by the American Gastroenterological Association for hemorrhoid management, including: Maintaining a high-fiber diet rich in vegetables and soft foods. Ensuring adequate hydration (1.5-2 litres of water per day). Engaging in regular physical activity. Avoiding prolonged sitting. Assessments and Monitoring: Participants underwent clinical evaluations and monitoring throughout the study. Key clinical parameters were assessed at four-time points: Baseline (Day 0, D0) Mid-treatment (Day 14, D14) End of treatment (Day 28, D28) Post-treatment follow-up (Day 35, D35) Laboratory tests, including liver and kidney function assessments, complete blood count, urinalysis, and colonoscopy, were conducted at baseline (D0) and treatment's end (D28).