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

NCT ID: NCT06876428

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hemorrhoids Second Degree Traditional Chinese Medicine (TCM)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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Do Thanh Sang

Lecturer, Department of Traditional Medicine, University of Medicine and Pharmacy at Ho Chi Minh City

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sang Do, MD

Role: CONTACT

+84 0948561030

Other Identifiers

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4046/ĐHYD- HĐĐĐ

Identifier Type: -

Identifier Source: org_study_id

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