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.

A Phase III, Multicenter, Randomized, Open-label, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Trĩ Thiên Dược Capsules in Grade II Internal Haemorrhoids Patients With Bleeding Compared to Diosmin.

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 Overview

• Status: Completed
• Conditions: Grade II Internal Hemorrhoids With Bleeding
• Intervention / Treatment: Drug: Intervention Group: Tri Thien Duoc Capsules; Drug: Control group (diosmin)

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 3

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Hanoi Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tri Thien Duoc capsules; Intervention Group: 86 participants with stage II hemorrhoids with bleeding	Drug: Intervention Group: Tri Thien Duoc Capsules; 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.
Active Comparator: Diosmin; Control group: 86 participants with stage II hemorrhoids with bleeding	Drug: Control group (diosmin); Control group: 86 patients took Daflon, 4 tablets/day for 28 days, monitored for 35 days from the start of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score during defecation	The average pain level score reported by patients during defecation, measured using the Visual Analog Scale (VAS).	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	The number of patients experiencing rebleeding out of the total number of patients in each group.	During 35 days of follow up
Degree of defecation disorder	The average Wexner Defecation Disorder Score, which quantifies the severity of defecation dysfunction.	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	the proportion of patients classified according to each degree of hemorrhoid severity, as determined by clinical examination and rigid sigmoidoscopy.	Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)
Anal mucosal condition	The percentage of patients classified according to the degree of hemorrhoidal engorgement, as assessed by rigid sigmoidoscopy.	Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)
Adverse Events	the proportion of patients who experienced a drug-related adverse event during the study period in each group.	During 28 days of treatment

Collaborators and Investigators

• Sponsor: Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): September 29, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Tri Thien Duoc; internal hemorrhoids; Portulaca Oleracea L.; Amaranthus Spinosus L.
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Pyrans; Benzopyrans; Flavonoids; Chromones; Flavones; Control Groups; Diosmin
• Other Study ID Numbers: 65/CN-HĐĐĐ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results

IPD Sharing 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

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No