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A Randomized Controlled Trial of Yanghuo Huoxue Decoction Combined with Low-Dose Tadalafil for Type 2 Diabetic Erectile Dysfunction with Kidney Deficiency and Blood Stasis Pattern

A Randomized Controlled Trial of Yanghuo Huoxue Decoction Combined with Low-Dose Tadalafil for Type 2 Diabetic Erectile Dysfunction with Kidney Deficiency and Blood Stasis Pattern

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100809
Enrollment
Unknown
Registered
2025-04-15
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Diabetic erectile dysfunction

Interventions

Treatment group:In combination with conventional therapy, patients received orally administered Yanghuo Huoxue Decoction modified based on syndrome differentiation. Administration protocol: 200 mL per
Control group:In combination with conventional therapy, patients received oral tadalafil (5 mg per dose) administered every other day at approximately 15:00 hours, with a total treatment course of 12

Sponsors

Shenzhen Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) Those who meet the Western medical diagnostic criteria for diabetes mellitus and erectile dysfunction, and the ED diagnosis is after DM; (2) Blood glucose has been controlled at a good level, FPG<=7.0mmol/L, postprandial 2hPG<=10.0mmol/L, glycosylated hemoglobin <=7.0%; (3) Those who meet the TCM diagnostic criteria for diabetic erectile dysfunction (kidney deficiency and blood stasis syndrome); (4) Men < 20 years old < 60 years old with normal libido; (5) Those who voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with type 1 diabetes or type 2 diabetes who have no sexual life; (2) Patients with severe cardiovascular disease, cerebrovascular disease, liver and kidney insufficiency, hematopoietic system disease, and neuropathy; (3) Combined with urethritis, acute prostatitis, urinary stones and other diseases; (4) History of pelvic surgery or within 6 months; (5) Those who take diuretics, antihypertensive drugs, sedatives, antidepressants, hormones and related drugs for a long time.

Design outcomes

Primary

MeasureTime frame
Score of the 5-item International Index of Erectile Function (IIEF-5) questionnaire;Quality of Erection Questionnaire (QEQ) score;Erectile Hardness Score (EHS);Chinese Medical Syndrome Scores;

Secondary

MeasureTime frame
Serum homocysteine (HCY) ;Fasting plasma glucose (FPG);2-hour postprandial glucose (2hPG);Glycated hemoglobin (HbA1c);Prostacyclin (PGI2);Endothelin(ET);Serum nitric oxide (NO) levels;Total Antioxidant Capacity (T-AOC);lutathione Peroxidase (GSH-Px);Total Cholesterol (TC);Triglyceride (TG);

Countries

China

Contacts

Public ContactHong Zhiming

Shenzhen Traditional Chinese Medicine Hospital

hzm001983@126.com+86 136 3169 9269

Outcome results

None listed

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