type 2 diabetes mellitus erectile dysfunction
Conditions
Interventions
Control group:Simulated agent of Hong jing qi wei formula and tadalafil
Sponsors
Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Male
Age
22 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the western medical diagnostic criteria for type 2 diabetes mellitus and ED, and type 2 diabetes mellitus occurs before the diagnosis of ED; (2) Meet the TCM diagnostic criteria of kidney deficiency and blood stasis syndrome; (3) Age: 22 = age = 65 years old; (4)Glycosylated hemoglobin <7%; (5)IIEF-5 score =21; (6) have a regular sexual partner and stable sex life, and still expect to maintain an active sex life with the sexual partner during the study period, at least 1 time per week; (7) Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) People with severe psychosomatic factors or history of psychiatric disorders, or those with SAS > 69 or SDS > 72 or those who are unable to guarantee that they will stop using anti-anxiety or depression medication during the trial period; (2) Clinically significant penile anatomical or structural abnormalities (including but not limited to) as determined by the investigator: e.g., small penis, congenital curvature of the penis, penile cavernous fibrosis; (3) Patients with this disease due to other sexual dysfunction disorders (e.g., ejaculatory disorders, premature ejaculation) or incurable endocrine disorders (e.g., hypogonadism, hyperprolactinemia, hyper/hypothyroidism, Cushing's disease, or hypopituitarism, etc.); (4) Erectile dysfunction due to spinal cord/nerve injury or radical prostate cancer or other trauma, surgery, or radiation therapy; (5) A history of one of the following cardiac conditions a Myocardial infarction, shock, or life-threatening arrhythmia within the last 6 months; b Unstable angina pectoris within the last 3 months or previous angina pectoris during sexual intercourse; c Coronary artery bypass grafting within the last 3 months, or percutaneous coronary intervention; d New York Heart Association (NYHA) = Class II heart failure within the past 6 months; (6) Significant hepatic or renal dysfunction (liver function ALT and/or AST greater than 1.5 times the upper limit of normal, or creatinine greater than 20% of the upper limit of normal); (7) History of severe central nervous system injury (cerebrovascular disease such as cerebral ischemia or hemorrhage, inflammatory brain disease such as encephalitis or meningitis, craniocerebral trauma or spinal cord injury) or peripheral muscular neurological disease within the past 6 months; (8) Known to have abnormal color vision, pigmentary retinitis, macular degeneration, non-arteritic anterior ischemic optic neuropathy ocular diseases; (9) Persons with a history of malignant tumors; (10) Persons with a known prior history of sudden hearing loss or hearing loss; (11) Penile prosthesis installers; (12) Those who are allergic to PDE5i drugs, or whose treatment for erectile dysfunction is ineffective or who have had adverse reactions that led to the discontinuation of the drug; (13) Those who are currently using the drug regularly (for more than 1 month) and are unable to stop the use of nitrates or NO donors, anti-androgens, guanylate cyclase agonists, or other drugs or treatments for erectile dysfunction during the study period; (14) The patient's sexual partner is breastfeeding or pregnant or preparing for pregnancy, or is undergoing treatment for a gynecological condition that restricts sexual activity; (15) Participation in other trials in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Index of Erectile Function-5; | — |
Secondary
| Measure | Time frame |
|---|---|
| Erection Hardness Score;Sexual Encounter Profile question 2;Sexual Encounter Profile question 3;Chinese Medicine Symptom Score; | — |
Countries
China
Contacts
Public ContactGuo Jun
Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Outcome results
None listed