Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 7:43 AM
Study NCT ID:
NCT07369635
Status:
COMPLETED
Last Update Posted:
2026-01-27
First Post:
2026-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D004145', 'term': 'Diosmin'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D047309', 'term': 'Flavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 172 participants with grade II internal hemorrhoids with bleeding were enrolled in the study and allocated as follows:\n\nIntervention 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.\n\nControl 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.\n\nAll participants in this Phase III study adhered to the dietary and lifestyle recommendations outlined by the American Gastroenterological Association for hemorrhoid management, including:\n\nMaintaining 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2026-01-18', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean duration of rectal bleeding', 'timeFrame': 'Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)', 'description': 'Mean duration of fresh rectal bleeding episodes: Defined as the mean number of days the patient experiences fresh rectal bleeding.'}, {'measure': 'Rate of cessation of rectal bleeding', 'timeFrame': 'Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)', 'description': 'Defined as the proportion of patients who achieve complete cessation of fresh rectal bleeding out of the total number of patients'}, {'measure': 'Severity of hemorrhoidal symptoms', 'timeFrame': 'Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)', 'description': 'the mean symptom score of participants according to the Sodergren scale.'}], 'secondaryOutcomes': [{'measure': 'Pain score during defecation', 'timeFrame': 'Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)', 'description': 'The average pain level score reported by patients during defecation, measured using the Visual Analog Scale (VAS).'}, {'measure': 'Rate of recurrent bleeding', 'timeFrame': 'During 35 days of follow up', 'description': 'The number of patients experiencing rebleeding out of the total number of patients in each group.'}, {'measure': 'Degree of defecation disorder', 'timeFrame': 'Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)', 'description': 'The average Wexner Defecation Disorder Score, which quantifies the severity of defecation dysfunction.'}, {'measure': 'Degree of hemorrhoid prolapse', 'timeFrame': 'Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)', 'description': 'the proportion of patients classified according to each degree of hemorrhoid severity, as determined by clinical examination and rigid sigmoidoscopy.'}, {'measure': 'Anal mucosal condition', 'timeFrame': 'Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment)', 'description': 'The percentage of patients classified according to the degree of hemorrhoidal engorgement, as assessed by rigid sigmoidoscopy.'}, {'measure': 'Adverse Events', 'timeFrame': 'During 28 days of treatment', 'description': 'the proportion of patients who experienced a drug-related adverse event during the study period in each group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tri Thien Duoc', 'internal hemorrhoids', 'Portulaca Oleracea L.', 'Amaranthus Spinosus L.'], 'conditions': ['Grade II Internal Hemorrhoids With Bleeding']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Study Design:\n\nThis 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).\n\nParticipants:\n\nA total of 172 participants with grade II internal hemorrhoids with bleeding were enrolled in the study and allocated as follows:\n\nIntervention 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.\n\nControl 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.\n\nStudy Procedures:\n\nAll participants in this Phase III study adhered to the dietary and lifestyle recommendations outlined by the American Gastroenterological Association for hemorrhoid management, including:\n\nMaintaining 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.\n\nAssessments and Monitoring:\n\nParticipants underwent clinical evaluations and monitoring throughout the study. Key clinical parameters were assessed at four-time points:\n\nBaseline (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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '\\- Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible for the study:\n\n* Age 18 to 65 years\n* Diagnosis of grade II internal hemorrhoids with bleeding, presenting with the following symptoms:\n\nHemorrhoids prolapse with gentle straining and retract spontaneously Presence of blood in stool Congested and/or bleeding hemorrhoids\n\n* Having symptoms such as anal pain and anal itching\n* Willingness to voluntarily participate in the study - Exclusion Criteria\n\nPatients meeting any of the following criteria will be excluded from the study:\n\n* History of malignancy, including colon cancer and other cancers\n* Anal polyps and proctitis\n* Anal fissures with bleeding\n* Systemic diseases, such as hypertension, liver failure, kidney failure, heart failure, and coagulation disorders.\n* Other severe acute or chronic illnesses\n* Mixed hemorrhoids or conditions requiring immediate surgical intervention, such as hematoma, severe bleeding, or hemorrhoidal infarction\n* Recent use of other hemorrhoid medications (within 7 days prior to study enrollment)\n* Known allergy to any component of the study medications\n* Pregnant or lactating women\n* 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.'}, 'identificationModule': {'nctId': 'NCT07369635', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Hanoi Medical University'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '65/CN-HĐĐĐ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tri Thien Duoc capsules', 'description': 'Intervention Group: 86 participants with stage II hemorrhoids with bleeding', 'interventionNames': ['Drug: Intervention Group: Tri Thien Duoc Capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diosmin', 'description': 'Control group: 86 participants with stage II hemorrhoids with bleeding', 'interventionNames': ['Drug: Control group (diosmin)']}], 'interventions': [{'name': 'Intervention Group: Tri Thien Duoc Capsules', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Tri Thien Duoc capsules']}, {'name': 'Control group (diosmin)', 'type': 'DRUG', 'description': 'Control group: 86 patients took Daflon, 4 tablets/day for 28 days, monitored for 35 days from the start of treatment.', 'armGroupLabels': ['Diosmin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Hanoi Medical University Hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 3 months and ending 3 years after the publication of results', 'ipdSharing': 'YES', 'description': 'All IPD collected throughout the trial', 'accessCriteria': '* Criteria for Data Sharing:\n\n * Data will only be shared if it serves a valid scientific purpose (e.g., verifying results, conducting meaningful new analyses).\n * The statistical methods must be reviewed and approved by experts or an independent committee before use.\n* Mechanism for Data Sharing:\n\n * Researchers must submit a proposal describing their study and analysis methods.\n * They must sign a confidentiality and data use agreement.\n * Once approved, the data will be provided through a secure system'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanoi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}