Traditional Medicine Syndromes in Internal Hemorrhoids: a Cross-Sectional Study (TMS-Hemorrhoid)
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sang Do, MD
- Phone Number: +84 0948561030
- Email: dtsang@ump.edu.vn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of Traditional Medicine Syndromes in Internal Hemorrhoid Patients
Time Frame: Baseline assessment at the time of patient enrollment (within the first visit).
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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.
|
Baseline assessment at the time of patient enrollment (within the first visit).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4046/ĐHYD- HĐĐĐ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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