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NCT Number: NCT07487181

A Survey of Traditional Medicine Pattern Identification in Patients With Erectile Dysfunction

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.

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Key information

Conditions

Erectile Dysfunctions Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals aged 18 years or older who were diagnosed with erectile dysfunction by a clinical physician at Binh Dan Hospital between January 2026 and August 2026.
  • Willing to participate in the study and provide informed consent.

Exclusion criteria

  • Unable to understand the questionnaire.
  • Unable to complete all the study questions.
  • Patients who do not wish to continue participating in the study.

Treatment and study plan

Primary outcomes

  1. Traditional medicine pattern identification

    Time frame: At the time of enrollment in the study

  2. Severity of erectile dysfunction according to the International Index of Erectile Function-5 (IIEF-5) score

    Time frame: At the time of enrollment in the study

    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.

  3. 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

    Time frame: At the time of enrollment in the study

    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

  4. The associations between traditional medicine syndrome patterns and demographic, clinical, and lifestyle characteristics

    Time frame: At the time of enrollment in the study

    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).

Study contacts

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

Giang Binh Pham Le Medical doctor

CONTACT

[email protected]

+84346194876

Minh Man Bui Pham Doctor of Phylosophy

CONTACT

[email protected]

+84916080803

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Traditional Medicine Pattern Distribution in Patients With Erectile Dysfunction: A Cross-sectional Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Aug 26, 2026

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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