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.

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).

• Inclusion Criteria

Patients must meet all of the following criteria to be eligible for the study:

• Age 18 to 65 years
• Diagnosis of grade II internal hemorrhoids with bleeding, presenting with the following symptoms:

Hemorrhoids prolapse with gentle straining and retract spontaneously Presence of blood in stool Congested and/or bleeding hemorrhoids

• Having symptoms such as anal pain and anal itching
• Willingness to voluntarily participate in the study - Exclusion Criteria

Patients meeting any of the following criteria will be excluded from the study:

• History of malignancy, including colon cancer and other cancers
• Anal polyps and proctitis
• Anal fissures with bleeding
• Systemic diseases, such as hypertension, liver failure, kidney failure, heart failure, and coagulation disorders.
• Other severe acute or chronic illnesses
• Mixed hemorrhoids or conditions requiring immediate surgical intervention, such as hematoma, severe bleeding, or hemorrhoidal infarction
• Recent use of other hemorrhoid medications (within 7 days prior to study enrollment)
• Known allergy to any component of the study medications
• Pregnant or lactating women
• Patients will be withdrawn from the study if they: Do not adhere to the treatment regimen, including missing medication for more than 3 consecutive days. Or Use other prohibited medications during the study period. Or require routine medical care at the hospital due to non-compliance or other medical reasons.