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.

NCT07369635 | Completed Phase 3 DMC

• 1 other identifier: 65/CN-HĐĐĐ
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Grade II Internal Hemorrhoids With Bleeding

Keywords

Tri Thien Duoc; internal hemorrhoids; Portulaca Oleracea L.; Amaranthus Spinosus L.

Outcome Measures

Primary Outcomes (3)

• Mean duration of rectal bleeding

  Mean duration of fresh rectal bleeding episodes: Defined as the mean number of days the patient experiences fresh rectal bleeding.

  Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)

• Rate of cessation of rectal bleeding

  Defined as the proportion of patients who achieve complete cessation of fresh rectal bleeding out of the total number of patients

  Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)

• Severity of hemorrhoidal symptoms

  the mean symptom score of participants according to the Sodergren scale.

  Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)

Secondary Outcomes (6)

• Pain score during defecation

  Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)

• Rate of recurrent bleeding

  During 35 days of follow up

• Degree of defecation disorder

  Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)

• Degree of hemorrhoid prolapse

  Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)

• Anal mucosal condition

  Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)

Study Arms (2)

Tri Thien Duoc capsules

EXPERIMENTAL

Intervention Group: 86 participants with stage II hemorrhoids with bleeding

Drug: Intervention Group: Tri Thien Duoc Capsules

Diosmin

ACTIVE COMPARATOR

Control group: 86 participants with stage II hemorrhoids with bleeding

Drug: Control group (diosmin)

Interventions

Intervention Group: Tri Thien Duoc Capsules DRUG

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.

Tri Thien Duoc capsules

Control group (diosmin) DRUG

Control group: 86 patients took Daflon, 4 tablets/day for 28 days, monitored for 35 days from the start of treatment.

Diosmin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University Hospital

Hanoi, 100000, Vietnam

Location

MeSH Terms

Interventions

Control Groups; Diosmin

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. 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.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: July 10, 2020
• Primary Completion: September 29, 2020
• Study Completion: November 30, 2020
• Last Updated: January 27, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: * 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

Locations

VN (1)