Erectile DysfunctionsNCT07487181
A Survey of Traditional Medicine Pattern Identification in Patients With Erectile Dysfunction
An observational study of Erectile Dysfunctions, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunctions
- How many people
- 375 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Jan 2026to 30 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Individuals aged 18 years or older diagnosed with erectile dysfunction at Binh Dan Hospital
Who may be able to join
- 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.
Who cannot join
- Unable to understand the questionnaire.
- Unable to complete all the study questions.
- Patients who do not wish to continue participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Binh Dan Hospital, Ho Chi Minh city
Ho Chi Minh City
Minh Man Bui Pham Doctor of Phylosophy, +84916080803, bpmman@uhsvnu.edu.vn
Giang Binh Pham Le Medical Doctor, +84346194876, plgbinh.ths.yhct24@ump.edu.vn
About this study
Official title: Traditional Medicine Pattern Distribution in Patients With Erectile Dysfunction: A Cross-sectional Study
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.
Read the 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.
- Conditions
- Erectile Dysfunctions
- Keywords
- Traditional Medicine Pattern, Erectile Dysfunctions, IIEF-5
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Men aged ≥18 years diagnosed with erectile dysfunction at Binh Dan Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional medicine pattern identification
Measured: 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.
Measured: 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
Measured: 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).
Measured: At the time of enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start14 Jan 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 375 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487181
- Sponsor's protocol ID
- 148/DHYD-HDDD
- Status last verified
- Nov 2025
- First submitted
- 17 Mar 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28523265Burnett 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.
PubMed 29746858Capogrosso 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.
PubMed 40393866