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Clinical Study on the Treatment of Erectile Dysfunction with Huashi Tongbi Prescription

Clinical Study on the Treatment of Erectile Dysfunction with Huashi Tongbi Prescription

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067825
Enrollment
Unknown
Registered
2023-01-28
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

erectile dysfunction

Interventions

Contral group:Sildenafil citrate tablets, 50 mg, take orally as needed
Treatment group:Huashi Tongbi Formula, 200 ml/bag, 2 bags/day

Sponsors

Xiyuan Hospital, China Academy of Chinese Medicine Science
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Conforming to the diagnostic criteria of traditional Chinese medicine for erectile dysfunction of damp heat accumulating spleen type; 2. International Erectile Function Questionnaire-5 (IIEF-5) score <= 21; 3. Aged 22-50 years; 4. Those who have a fixed sexual partner and regular sexual life, have sex once a week or more, and can cooperate to complete the test; 5. Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed patients with severe traumatic ED; 2. Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, sickle cell anemia, multiple myeloma, leukemia and other serious diseases; 3. People with severe intestinal diseases, such as ulcerative colitis, Crohn's disease, rectal cancer, which may affect the fecal flora; 4. Take anti anxiety and anti depression drugs regularly for a long time; 5. Patients who have taken drugs that may affect this study in the past month or participated in other clinical investigators; 6. Those who have a birth plan during the treatment and within 3 months after the treatment; 7. Those who need to take nitrates regularly for a long time, such as nitroglycerin, isosorbide mononitrate, etc.

Design outcomes

Primary

MeasureTime frame
International Index of Erectile Function-5, IIEF-5;TCM Syndrome Grading and Quantitative Scoring;EQS, Erectile Quality Scale;

Secondary

MeasureTime frame
sex hormone;Patient Health Questionnaire (PHQ-9);Generalised Anxiety Disorder (GAD-7) Scoring;

Countries

China

Contacts

Public ContactZhao Jiayou

Xiyuan Hospital, China Academy of Chinese Medicine Science

zhaojiayou520@126.com+86 18810599934

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026