An observational study in Hemorrhoids Second Degree and Traditional Chinese Medicine (TCM), sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Observational
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 150 is close to the median of 151 across 49 observational studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
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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
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Baseline assessment at the time of patient enrollment (within the first visit).
No study locations are listed for this record.
Plan to share: Yes — Individual Participant Data (IPD) will not be shared publicly. Aggregated data will be reported in scientific publications. Only summary statistics and de-identified data may be available upon reasonable request for research purposes.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Medicine and Pharmacy at Ho Chi Minh City →