Traditional Medicine Syndromes in Internal Hemorrhoids: a Cross-Sectional Study

NCT06876428 | Not Yet Recruiting DMC

• 1 other identifier: 4046/ĐHYD- HĐĐĐ
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Hemorrhoids Second Degree; Traditional Chinese Medicine (TCM)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline assessment at the time of patient enrollment (within the first visit).

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Central Study Contacts

Sang Do, MD

CONTACT

+84 0948561030; dtsang@ump.edu.vn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 18 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Traditional Medicine, University of Medicine and Pharmacy at Ho Chi Minh City

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR