Traditional Medicine Syndromes in Internal Hemorrhoids: a Cross-Sectional Study (TMS-Hemorrhoid)

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Not yet enrolling

Conditions: Traditional Chinese Medicine (TCM); Hemorrhoids Second Degree

Study type: Observational

Funder types: Other

Identifiers

NCT06876428

4046/ĐHYD- HĐĐĐ

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Internal Hemorrhoid Patients with Traditional Medicine Syndrome Classification

Description:

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.