Grade II Internal Hemorrhoids With BleedingPhase 3NCT07369635
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 3 study testing Intervention Group: Tri Thien Duoc Capsules in people with Grade II Internal Hemorrhoids With Bleeding, run by Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Grade II Internal Hemorrhoids With Bleeding
- What is being tested?
- Intervention Group: Tri Thien Duoc Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Jul 2020to 30 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Intervention Group: Tri Thien Duoc Capsules, Control group (diosmin)
- Keywords
- Tri Thien Duoc, internal hemorrhoids, Portulaca Oleracea L., Amaranthus Spinosus L.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group: Tri Thien Duoc CapsulesDrug
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 (diosmin)Drug
Control group: 86 patients took Daflon, 4 tablets/day for 28 days, monitored for 35 days from the start of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Tri Thien Duoc capsules | Experimental | Intervention Group: 86 participants with stage II hemorrhoids with bleeding Receives: Drug: Intervention Group: Tri Thien Duoc Capsules |
| Diosmin | Active comparator | Control group: 86 participants with stage II hemorrhoids with bleeding Receives: Drug: Control group (diosmin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
The average pain level score reported by patients during defecation, measured using the Visual Analog Scale (VAS).
Measured: 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.
Measured: During 35 days of follow up
Degree of defecation disorder
The average Wexner Defecation Disorder Score, which quantifies the severity of defecation dysfunction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start10 Jul 2020
- Primary completion29 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade II Internal Hemorrhoids With BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369635
- Sponsor's protocol ID
- 65/CN-HĐĐĐ
- Status last verified
- Mar 2025
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07369635
- Acronym / sponsor ID
- 65/CN-HĐĐĐ
- Keywords
- Tri Thien Duoc, internal hemorrhoids, Portulaca Oleracea L., Amaranthus Spinosus L.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tri Thien Duoc capsules | Experimental | Drug: Intervention Group: Tri Thien Duoc CapsulesIntervention Group: 86 participants with stage II hemorrhoids with bleeding |
| Diosmin | Active comparator | Drug: Control group (diosmin)Control group: 86 participants with stage II hemorrhoids with bleeding |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group: Tri Thien Duoc CapsulesIntervention 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. | Drug | Tri Thien Duoc capsules |
| Control group (diosmin)Control group: 86 patients took Daflon, 4 tablets/day for 28 days, monitored for 35 days from the start of treatment. | Drug | Diosmin |
Primary outcome
Mean duration of rectal bleeding
Time frame: Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)
Mean duration of fresh rectal bleeding episodes: Defined as the mean number of days the patient experiences fresh rectal bleeding.
Rate of cessation of rectal bleeding
Time frame: Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)
Defined as the proportion of patients who achieve complete cessation of fresh rectal bleeding out of the total number of patients
Severity of hemorrhoidal symptoms
Time frame: Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)
the mean symptom score of participants according to the Sodergren scale.
6 secondary outcomes
Pain score during defecation
Time frame: 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
Time frame: During 35 days of follow up
Degree of defecation disorder
Time frame: 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
Time frame: Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)
Anal mucosal condition
Time frame: Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)
Adverse Events
Time frame: During 28 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intervention Group: Tri Thien Duoc Capsules in people with Grade II Internal Hemorrhoids With Bleeding, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean duration of rectal bleeding (time frame: Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.