Male Erectile Dysfunction
Conditions
Interventions
Lipid-clearing Capsule Group:Lipid-clearing Capsules: Oral administration, 2 capsules per dose, twice daily, once in the morning and once in the evening.
Tadalafil group:Tadalafil tablets, 5 mg per dose, once daily, taken orally before bedtime.
Qingzhi Capsules combined with Tadalafil group.:Qingzhi Capsules: Take 2 capsules orally, twice a day, once in the morning and once in the evening.
Tadalafil Tablets: 5 mg per dose, once a day, to be
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
22 Years to 65 Years
Inclusion criteria
Inclusion criteria: Meets the Western medicine diagnostic criteria for type 2 diabetes mellitus (T2DM) and erectile dysfunction (ED), with T2DM preceding the onset of ED. Meets the Traditional Chinese Medicine (TCM) diagnostic criteria for Kidney Deficiency and Blood Stasis Syndrome. Male, aged between 22 and 65 years old. Blood sugar has been well controlled for the past 3 months: Glycated Hemoglobin (HbA1c) = 7%, fasting plasma glucose (FPG) = 7.0 mmol/L, and 2-hour postprandial glucose (2hPG) = 10.0 mmol/L. Simplified International Index of Erectile Function (IIEF-EF) score: 11 = IIEF-EF = 25, indicating mild to moderate ED. Capable of cooperating with the examination and treatment process, has a stable sexual partner and regular sexual activity, and can complete the related questionnaires. The subject is informed, and either the individual or their family has voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with significant penile deformities such as micropenis, congenital penile curvature, penile fibrosis, or a history of related surgeries involving the prostate, pelvis, or lower abdomen. 2. Subjects with erectile dysfunction caused by other sexual dysfunctions (such as ejaculation disorders, premature ejaculation) or incurable endocrine diseases (e.g., hypogonadism, hyperprolactinemia, hyperthyroidism/hypothyroidism, Cushing's disease, or pituitary insufficiency). 3. Subjects with a history of severe psychological factors or mental disorders, or those with severe anxiety (GAD score = 15) or depression (PHQ score = 15) or who are unable to discontinue anti-anxiety or antidepressant medications during the trial. 4. Subjects with erectile dysfunction caused by spinal cord/nerve injury, radical prostatectomy, or other trauma, surgeries, or radiation therapy. 5. Subjects with a history of the following heart conditions: a. Myocardial infarction, shock, or life-threatening arrhythmia within the last 6 months. b. Unstable angina within the last 3 months or a history of angina during sexual intercourse. c. Coronary artery bypass graft surgery or percutaneous coronary intervention within the last 3 months. d. Heart failure (NYHA Class II or above) within the last 6 months. e. Uncontrolled arrhythmia. 6. Subjects with acute diabetes complications within the last 3 months, such as diabetic ketoacidosis or hyperosmolar non-ketotic coma, or with significant chronic complications such as proliferative retinopathy, stage IV or more severe renal impairment, or severe diabetic neuropathy. 7. Subjects with severe renal disease or estimated glomerular filtration rate (eGFR, CKD-EPI formula) = 60 mL/min/1.73 m². 8. Subjects with poorly controlled blood pressure (defined as systolic pressure = 180 mmHg and/or diastolic pressure = 110 mmHg) or with clinical hypotension. If a subject meets this exclusion criterion, a second measurement can be taken after at least 30 minutes, and the second result will determine the subject's eligibility. 9. Subjects with significant liver disease or acute or chronic hepatitis, or laboratory tests showing ALT or AST = 3 times the upper limit of normal (ULN) and total bilirubin (TBIL) = 2 times the ULN. 10. Subjects with a history of severe central nervous system damage (e.g., cerebral ischemia, stroke), inflammatory brain diseases (e.g., encephalitis, meningitis), traumatic brain or spinal cord injury, or peripheral neuromuscular disorders within the past 6 months. 11. Subjects with a history of malignancy. 12. Subjects with penile implants. 13. Subjects currently using (for more than 1 month) and unable to discontinue the use of nitrates or NO donors, guanylate cyclase stimulators, hormones, beta-blockers, antidepressants, sedatives, or other medications or therapies for erectile dysfunction during the study period. 14. Subjects allergic to the study drug components or with a history of severe allergic reactions. 15. Subjects whose sexual partners are breastfeeding, pregnant, planning pregnancy, or undergoing treatment for gynecological conditions that limit sexual activity. 16. Subjects with a history of drug abuse or alcohol dependence. 17. Subjects who have participated in another clinical trial within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IIEF-EF scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| IIEF-EF scores;Sexual Encounter Profile (SEP) – Questions 2 and 3;Erection hardness grading scale, EHS;Penile Erection Satisfaction;The Traditional Chinese Medicine (TCM) Syndrome Efficacy Score Index; | — |
Countries
China
Contacts
Public ContactZheng Li
Shanghai General Hospital
Outcome results
None listed