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

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.

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Key information

Conditions

Hemorrhoids Second Degree Traditional Chinese Medicine (TCM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sang Do, MD

CONTACT

[email protected]

+84 0948561030

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Survey on the Characteristics of Traditional Medicine Syndromes in Patients with Internal Hemorrhoids At Le Van Thinh Hospital

Acronym: TMS-Hemorrhoid

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 14, 2025
Registry last updated: Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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