Erectile dysfunction
Conditions
Interventions
Investigational drug:Ela Tablets
Comparator:Ela Tablets placebo
Sponsors
The First Affiliated HospitalSun Yat-Sen University
Eligibility
Sex/Gender
Male
Age
22 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male 22 years = age = 65 years ; 2.Meet the diagnostic criteria for erectile dysfunction and the duration of the disease = 3 months ; 3.Meet the classification criteria of Uygur medical damp and cold Male weakness; 4.Meet the diagnostic criteria of TCM life-gate fire failure ; 5.Visit 1: The International Index of Erectile Function-5 (IIEF-5) score = 8 and = 21 points; 6.Have a stable adult female partner who remains sexually active (agrees to have at least 4 attempts at intercourse during each visit cycle) for 3 months prior to the trial and during the study; 7.The number of sexual intercourse attempts during the lead-in period = 4 and the IIEF-EF score at Visit 2 was = 11 and = 25 ; 8. give informed consent to this trial voluntarily sign a written informed consent form be able to maintain good communication with the investigator and comply with various requirements of the clinical trial (planned visits laboratory tests and other trial procedures etc.)
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to the components of Ela Tablets and their placebo; 2.Patients with penile erectile dysfunction caused by congenital malformations or anatomical abnormalities of the genitals (penile deviation cavernous fibrosis Peyronie's disease etc.). 3.Patients with erectile dysfunction caused by spinal cord injury or radical prostatectomy; 4.Erectile dysfunction caused by other sexual dysfunction diseases (such as ejaculation disorders premature ejaculation) or uncontrolled endocrine diseases (such as hypogonadism hyperlactemia hyperthyroidism or hypothyroidism adrenal insufficiency or hyperactivity panhypopituitarism and multiple endocrine diseases) or drugs (antihypertensives antidepressants antipsychotics antiandrogens antihistamines etc.). 5.Those who are using vacuum negative pressure therapy (VCD) cavernous injection therapy (ICI) and other drugs or means to treat erectile dysfunction and cannot stop treatment during the study period; 6.Those with a history of penile implantation; 7. Combined with diseases that are easy to cause priapism such as sickle cell anemia multiple myeloma leukemia etc 8.Those with sexually transmitted diseases at the time of screening including but not limited to syphilis gonorrhea genital warts genital herpes AIDS etc 9.Patients with a history of any of the following pelvic diseases: a. pelvic surgery or any other procedure that invades the pelvis (e.g. prostatectomy pelvic surgery to remove malignancy or bowel resection) b. Pelvic radiation therapy c. Any pelvic surgery of the urinary tract (including minimal invasive prostatic hyperplasia with lower urinary tract symptoms BPH-LUTS treatment and penile implantation surgery) d. Malignant tumor or trauma of the lower urinary tract 10.Those with a history of any of the following heart diseases: a. Myocardial infarction shock or life-threatening arrhythmia within 6 months b. Unstable angina or coronary artery bypass graft surgery within 3 months or percutaneous coronary intervention c. Angina pectoris during sexual intercourse d. New York Heart Association NUHA class = II. in patients with heart failure e. Left ventricular outflow tract obstruction (e.g. aortic stenosis idiopathic hypertrophic subvalvular stenosis) 11.Patients with uncontrolled hypotension (160/100 mmHg) or diabetes mellitus (fasting blood glucose > 11.1 mmol/L) or diabetes mellitus complications (such as diabetic nephropathy peripheral neuropathy). 12.Patients with malignant tumors or other serious primary diseases of important organs and systems such as heart liver kidney and hematopoietic system or ALT and AST = twice the upper limit of normal value and Scr > upper limit of normal value 13.Those who suspect or have a history of alcohol and drug abuse 14.Those who are unable or unwilling to cooperate due to comorbid mental illness 15.Those who are positive for any of human immunodeficiency virus (HIV) antibodies treponema pallidum antibodies hepatitis C virus (HCV) antibodies or hepatitis B surface antigen (HBsAg) positive and serum HBV-DNA = 1000 IU/mL (only in HBsAg-positive patients). 16.Subjects who plan to donate sperm during the study or within 3 months after the last dose those whose sexual partners have pregnancy plans and those who are unwilling to use effective contraception 17.Those who have received any other experimental drug treatment or participated in another interventional clinical trial within 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IIEF-EF score from baseline after 12 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| After 4 8 and 12 weeks of treatment 100 answered "yes" to question 1 of the Global Assessment Questionnaire (GAQ) Ratio change;;Change from baseline in IIEF-15 sexual satisfaction scores after 4 8 and 12 weeks of treatment;After 4 8 and 12 weeks of treatment 100 answered "yes" to question 2 of the Global Assessment Questionnaire (GAQ) The percentage changes.;Question 3 of the Partner Sex Life Diary (pSEP) questionnaire after 4 8 and 12 weeks of treatment was answered "Full. Percentage change of meaning;;Percentage of subjects with a normal (> 25) IIEF-EF score after 4 8 and 12 weeks of treatment;The disappearance rate of Uyghur medical symptoms and individual symptoms after 4, 8 and 12 weeks of treatment;;Change in IIEF-15 libido score from baseline after 4 8 and 12 weeks of treatment;Change in IIEF-15 orgasmic function score from baseline after 4 8 and 12 weeks of treatment;The disappearance rate of TCM syndrome and single symptom after 4, 8 and 12 weeks of treatment;;Change in overall satisfaction score from baseline in IIEF-15 after 4 8 and 12 weeks of treatment;;Change of IIEF-EF score from baseline after 4 and 8 weeks of treatment;;After 4 8 and 12 weeks of treatment the Sexual Life Diary (SEP) questionnaire answered "yes" to 100 of question 2 Ratio change;;After 4 8 and 12 weeks of treatment the Sexual Life Diary (SEP) questionnaire answered "yes" to question 3 of the hundred Ratio change;; | — |
Countries
China
Contacts
Public ContactDENG CHUNHUA
The First Affiliated HospitalSun Yat-Sen University
Outcome results
None listed