Hemorrhoids Second DegreeTMS-HemorrhoidNCT06876428
Traditional Medicine Syndromes in Internal Hemorrhoids: a Cross-Sectional Study
An observational study of Hemorrhoids Second Degree and Traditional Chinese Medicine (TCM), run by University of Medicine and Pharmacy at Ho Chi Minh City.
Trial summary
This study aims to investigate the characteristics of Traditional Medicine (TM) syndromes in patients diagnosed with internal hemorrhoids at Le Van Thinh Hospital. Internal hemorrhoids are a common anorectal disorder, and their classification in Traditional Medicine remains inconsistent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids Second Degree, Traditional Chinese Medicine (TCM)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Nov 2025
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will recruit outpatients diagnosed with internal hemorrhoids at the General Surgery Department of Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. Participants will be assessed for Traditional Medicine (TM) syndromes and classified based on Goligher's hemorrhoid grading system. The study aims to determine the prevalence of TM syndromes in internal hemorrhoid patients and analyze their correlation with disease severity. Eligible participants are adults (≥18 years old) who meet the inclusion criteria and are willing to participate
Who may be able to join
- Patients aged 18 years or older.
- Diagnosed with internal hemorrhoids at Le Van Thinh Hospital using Goligher's classification.
- Willing to participate and provide informed consent
Who cannot join
- Patients with colorectal cancer or other serious gastrointestinal diseases.
- Patients with acute inflammatory bowel disease that may interfere with the diagnosis.
- Patients with severe chronic illnesses affecting overall health.
- Patients unable to complete the study questionnaire due to cognitive or language barriers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Survey on the Characteristics of Traditional Medicine Syndromes in Patients with Internal Hemorrhoids At Le Van Thinh Hospital
This study aims to investigate the characteristics of Traditional Medicine (TM) syndromes in patients diagnosed with internal hemorrhoids at Le Van Thinh Hospital. Internal hemorrhoids are a common anorectal disorder, and their classification in Traditional Medicine remains inconsistent. The study will examine the prevalence of TM syndromes in patients with internal hemorrhoids and assess the correlation between Goligher's classification and TM diagnoses.
The study will follow a cross-sectional observational design with an estimated 178 participants. Eligible patients are 18 years or older, diagnosed with internal hemorrhoids, and willing to participate. The primary outcomes include the prevalence of TM syndromes in internal hemorrhoids, severity classification according to Goligher's scale, and correlation analysis between TM syndromes and clinical severity.
The study has received approval from the Institutional Review Board (IRB) of the University of Medicine and Pharmacy at Ho Chi Minh City and will be conducted from December 2024 to April 2025 at Le Van Thinh Hospital, Vietnam.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Internal Hemorrhoid Patients with Traditional Medicine Syndrome Classification | This cohort consists of patients diagnosed with internal hemorrhoids based on modern medical criteria (Goligher's classification) and further classified into Traditional Medicine (TM) syndromes. Patients will undergo TM syndrome differentiation, including syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Spleen Qi Deficiency. The study aims to identify the prevalence of TM syndromes in internal hemorrhoid patients and explore their correlation with disease severity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Traditional Medicine Syndromes in Internal Hemorrhoid Patients
This outcome measures the proportion of patients diagnosed with internal hemorrhoids who exhibit specific Traditional Medicine (TM) syndromes. Patients will be assessed using TM diagnostic criteria to classify them into syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Spleen Qi Deficiency. The prevalence of each syndrome will be determined as a percentage of the total study population.
Measured: Baseline assessment at the time of patient enrollment (within the first visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoids Second DegreeStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Thanh Sang, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876428
- Sponsor's protocol ID
- 4046/ĐHYD- HĐĐĐ
- Acronym
- TMS-Hemorrhoid
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) will not be shared publicly. Aggregated data will be reported in scientific publications. Only summary statistics and de-identified data may be available upon reasonable request for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Characteristics of Traditional Medicine Syndromes in Patients with Internal Hemorrhoids At Le Van Thinh Hospital
- ClinicalTrials.gov ID
- NCT06876428
- Acronym / sponsor ID
- TMS-Hemorrhoid / 4046/ĐHYD- HĐĐĐ
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 14 Mar 2025 (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.
This study aims to investigate the characteristics of Traditional Medicine (TM) syndromes in patients diagnosed with internal hemorrhoids at Le Van Thinh Hospital. Internal hemorrhoids are a common anorectal disorder, and their classification in Traditional Medicine remains inconsistent. The study will examine the prevalence of TM syndromes in patients with internal hemorrhoids and assess the correlation between Goligher's classification and TM diagnoses.
The study will follow a cross-sectional observational design with an estimated 178 participants. Eligible patients are 18 years or older, diagnosed with internal hemorrhoids, and willing to participate. The primary outcomes include the prevalence of TM syndromes in internal hemorrhoids, severity classification according to Goligher's scale, and correlation analysis between TM syndromes and clinical severity.
The study has received approval from the Institutional Review Board (IRB) of the University of Medicine and Pharmacy at Ho Chi Minh City and will be conducted from December 2024 to April 2025 at Le Van Thinh Hospital, Vietnam.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 18 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internal Hemorrhoid Patients with Traditional Medicine Syndrome Classification | – | –This cohort consists of patients diagnosed with internal hemorrhoids based on modern medical criteria (Goligher's classification) and further classified into Traditional Medicine (TM) syndromes. Patients will undergo TM syndrome differentiation, including syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Spleen Qi Deficiency. The study aims to identify the prevalence of TM syndromes in internal hemorrhoid patients and explore their correlation with disease severity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit outpatients diagnosed with internal hemorrhoids at the General Surgery Department of Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. Participants will be assessed for Traditional Medicine (TM) syndromes and classified based on Goligher's hemorrhoid grading system. The study aims to determine the prevalence of TM syndromes in internal hemorrhoid patients and analyze their correlation with disease severity. Eligible participants are adults (≥18 years old) who meet the inclusion criteria and are willing to participate
Key inclusion criteria (3 listed)
- Patients aged 18 years or older.
- Diagnosed with internal hemorrhoids at Le Van Thinh Hospital using Goligher's classification.
- Willing to participate and provide informed consent
Key exclusion criteria (4 listed)
- Patients with colorectal cancer or other serious gastrointestinal diseases.
- Patients with acute inflammatory bowel disease that may interfere with the diagnosis.
- Patients with severe chronic illnesses affecting overall health.
- Patients unable to complete the study questionnaire due to cognitive or language barriers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Traditional Medicine Syndromes in Internal Hemorrhoid Patients
Time frame: Baseline assessment at the time of patient enrollment (within the first visit).
This outcome measures the proportion of patients diagnosed with internal hemorrhoids who exhibit specific Traditional Medicine (TM) syndromes. Patients will be assessed using TM diagnostic criteria to classify them into syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Spleen Qi Deficiency. The prevalence of each syndrome will be determined as a percentage of the total study population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) will not be shared publicly. Aggregated data will be reported in scientific publications. Only summary statistics and de-identified data may be available upon reasonable request for research purposes.
Related trials for Hemorrhoids Second Degree
Not yet recruitingPhase 2
Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Hemorrhoids Internal, Hemorrhoids Second Degree
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids Second Degree and Traditional Chinese Medicine (TCM), run by University of Medicine and Pharmacy at Ho Chi Minh City.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sang Do, MD (+84 0948561030, dtsang@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Traditional Medicine Syndromes in Internal Hemorrhoid Patients (time frame: Baseline assessment at the time of patient enrollment (within the first visit).). 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 14 Mar 2025.