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.

Hanoi Medical University

Status and phase

Completed

Phase 3

Conditions

Grade II Internal Hemorrhoids With Bleeding

Treatments

Drug: Control group (diosmin)

Drug: Intervention Group: Tri Thien Duoc Capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT07369635

65/CN-HĐĐĐ

Details and patient eligibility

About

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.

Full description

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).

Enrollment

172 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

- 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.