An observational study in Erectile Dysfunctions, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Observational
Erectile dysfunction (ED) is a common condition that significantly affects quality of life, psychological well-being, and interpersonal relationships. In Traditional Medicine, ED is classified into different syndrome patterns, which are essential for guiding individualized treatment; however, evidence on their distribution and associated factors in Vietnam remains limited. This cross-sectional study aims to determine the distribution of Traditional Medicine syndrome patterns in patients with ED and to evaluate their associations with demographic characteristics, clinical features, psychological status, and lifestyle factors, thereby providing evidence to support improved diagnosis and integrative treatment approaches.
This is a cross-sectional observational study designed to characterize the distribution of Traditional Medicine (TM) syndrome patterns among adult male patients with erectile dysfunction (ED) and to explore their associations with demographic, clinical, psychological, anthropometric, and lifestyle characteristics.
The study will be conducted at Binh Dan Hospital. Male patients aged 18 years or older who meet the study criteria for ED will be recruited during the study period. Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5), a validated instrument used to identify and classify the severity of ED. Clinical information will be collected using a standardized data collection form.
TM syndrome patterns will be assessed according to predefined Traditional Medicine diagnostic criteria by appropriately trained clinicians. The assessment will be used to classify participants into the corresponding TM syndrome patterns. Demographic and clinical data will include age, educational level, age at first diagnosis of ED, ED severity, and relevant characteristics of erectile function. Anthropometric assessment will include body mass index (BMI), calculated from measured body weight and height. Information on relevant comorbidities, including hypertension, diabetes mellitus, and dyslipidemia, will also be recorded.
Psychological status will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21), with the relevant subscale(s) used to characterize psychological symptoms. Lifestyle information will include smoking and alcohol consumption. All study variables will be collected at the time of enrollment, consistent with the cross-sectional design.
The analysis will first describe the distribution of TM syndrome patterns among participants with ED. Subsequently, the associations between TM syndrome patterns and selected demographic, clinical, psychological, anthropometric, comorbidity, and lifestyle characteristics will be examined. These analyses will include age, age at first diagnosis of ED, BMI, educational level, ED severity and clinical characteristics, psychological status, smoking, alcohol consumption, and selected comorbidities. The study is observational and cross-sectional; therefore, the analyses are intended to identify distributions and statistical associations rather than establish temporal or causal relationships.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 375 is above the median of 130 across 125 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction 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.
Counted across the registry records on this site, refreshed daily.
Individuals aged 18 years or older diagnosed with erectile dysfunction at Binh Dan Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Traditional medicine pattern identification
Time frame: At the time of enrollment in the study
Severity of erectile dysfunction according to the International Index of Erectile Function-5 (IIEF-5) score
Erectile dysfunction severity will be assessed using the International Index of Erectile Function-5 (IIEF-5), a 5-item validated questionnaire assessing erectile function. The total score ranges from 5 to 25 points. Higher scores indicate better erectile function and less severe erectile dysfunction.
Time frame: At the time of enrollment in the study
Age, age at first diagnosis, BMI, educational level, severity of erectile dysfunction, clinical characteristics of penile erection in patients with erectile dysfunction, levels of depression, anxiety, and stress, comorbidities, and lifestyle factors
Age: Years Age at first diagnosis of ED: Years Body Mass Index (BMI): kg/m², calculated as weight (kg)/height (m)² Educational level: Categorical Severity of ED: IIEF-5 score, 5-25; higher scores indicate better erectile function Clinical characteristics of penile erection: Categorical Depression: DASS-21 depression subscale, 0-42; higher scores indicate greater severity Anxiety: DASS-21 anxiety subscale, 0-42; higher scores indicate greater severity Stress: DASS-21 stress subscale, 0-42; higher scores indicate greater severity Comorbidities: Categorical (hypertension, diabetes, dyslipidemia) Smoking: Categorical Alcohol consumption: Categorical
Time frame: At the time of enrollment in the study
The associations between traditional medicine syndrome patterns and demographic, clinical, and lifestyle characteristics
The associations between traditional medicine syndrome patterns and demographic, clinical, and lifestyle characteristics, including age, age at first diagnosis, body mass index (BMI), educational level, severity and clinical characteristics of erectile dysfunction, psychological status (stress), and lifestyle factors (smoking and alcohol consumption).
Time frame: At the time of enrollment in the study
Started Jan 2026 (actual). Primary completion is estimated for Sep 2026, 8 months after the start.
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