Clinical trial NCT06876428: Traditional Medicine Syndromes in Internal Hemorrhoids: a Cross-Sectional Study
Official title: Survey on the Characteristics of Traditional Medicine Syndromes in Patients with Internal Hemorrhoids At Le Van Thinh Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemorrhoids Second Degree
Traditional Chinese Medicine (TCM)
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Traditional Medicine Syndromes in Internal Hemorrhoid Patients
timeFrame: Baseline assessment at the time of patient enrollment (within the first visit).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: