- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487181
A Survey of Traditional Medicine Pattern Identification in Patients With Erectile Dysfunction
Traditional Medicine Pattern Distribution in Patients With Erectile Dysfunction: A Cross-sectional Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Giang Binh Pham Le Medical Doctor
- Phone Number: +84346194876
- Email: plgbinh.ths.yhct24@ump.edu.vn
Study Contact Backup
- Name: Minh Man Bui Pham Doctor of Phylosophy
- Phone Number: +84916080803
- Email: bpmman@uhsvnu.edu.vn
Study Locations
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Ho Chi Minh City, Vietnam
- Recruiting
- Binh Dan Hospital, Ho Chi Minh city
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Contact:
- Giang Binh Pham Le Medical Doctor
- Phone Number: +84346194876
- Email: plgbinh.ths.yhct24@ump.edu.vn
-
Contact:
- Minh Man Bui Pham Doctor of Phylosophy
- Phone Number: +84916080803
- Email: bpmman@uhsvnu.edu.vn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Men aged ≥18 years diagnosed with erectile dysfunction at Binh Dan Hospital
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Traditional medicine pattern identification
Time Frame: At the time of enrollment in the study
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At the time of enrollment in the study
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The associations between traditional medicine syndrome patterns and demographic, clinical, and lifestyle characteristics
Time Frame: At the time of enrollment in the study
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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).
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At the time of enrollment in the study
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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
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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.
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At the time of enrollment in the study
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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
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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
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At the time of enrollment in the study
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Collaborators and Investigators
Publications and helpful links
General Publications
- Burnett AL, Nehra A, Breau RH, Culkin DJ, Faraday MM, Hakim LS, Heidelbaugh J, Khera M, McVary KT, Miner MM, Nelson CJ, Sadeghi-Nejad H, Seftel AD, Shindel AW. Erectile Dysfunction: AUA Guideline. J Urol. 2018 Sep;200(3):633-641. doi: 10.1016/j.juro.2018.05.004. Epub 2018 May 7.
- Capogrosso P, Albersen M, Burnett AL, Cakir OO, Deho F, Morgado LA, Mulhall J, Salonia A, Sarikaya AF, Satchi M, Serefoglu EC, Shabbir M, Sokolakis I, Yap T, Castiglione F. Erectile Dysfunction: Update on Clinical Management. Eur Urol. 2025 Oct;88(4):388-399. doi: 10.1016/j.eururo.2025.05.004. Epub 2025 May 19.
- Van Vo T, Hoang HD, Thanh Nguyen NP. Prevalence and Associated Factors of Erectile Dysfunction among Married Men in Vietnam. Front Public Health. 2017 May 4;5:94. doi: 10.3389/fpubh.2017.00094. eCollection 2017.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 148/DHYD-HDDD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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