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).

- 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.

All IPD collected throughout the trial

Beginning 3 months and ending 3 years after the publication of results

• Criteria for Data Sharing:

  • Data will only be shared if it serves a valid scientific purpose (e.g., verifying results, conducting meaningful new analyses).
  • The statistical methods must be reviewed and approved by experts or an independent committee before use.

• Mechanism for Data Sharing:

  • Researchers must submit a proposal describing their study and analysis methods.
  • They must sign a confidentiality and data use agreement.
  • Once approved, the data will be provided through a secure system