Erectile Dysfunction
Conditions
Interventions
Control Group:The placebo group took 1 capsule 2 times a day. Treatment lasted for 3 months. The placebo and Life Enhancer probiotic capsules have the same appearance and weight. They are still produc
Test Group:Life Enhancer probiotic capsule set, take 1 capsule 2 times a day for 3 months.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Male aged = 20 years old and = 60 years old; (2) Meet the diagnostic criteria for mild or moderate erectile dysfunction before enrollment: the International Erectile Function Questionnaire-5 (IIEF-5) score is between 8 and 21, and the disease duration is =3 months. (3) Have a regular adult female partner for at least the last 3 months and during this trial, and expect to maintain a sexual life with this female partner during the trial; (4) Agree to attempt sexual intercourse at least 4 times every 4 weeks during the trial; agree to attend all appointments during clinical visits, and be able to complete all examinations and procedures required by the attending physician during routine clinical visits; (5) You have not received Chinese or Western medicine for the treatment of ED in the first week before the introduction period, you have not received acupuncture, massage and other external Chinese medicine treatments for ED in the first month, and you have not received vacuum erection devices or vacuum erection devices in the first 6 months. Low-energy extracorporeal shock wave therapy, negative pressure suction and other physical treatments; (6) Volunteer to be tested and be able to read, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who are known or suspected to be allergic or allergic to this experimental drug; (2) Patients have genital anatomical malformations that significantly impair erection, such as severe penile fibrosis, penile hemangioma, or cavernous sclerosis; (3) Myocardial infarction, angina, cerebrovascular accident, heart failure, severe arrhythmia and other diseases occurred in the past 6 months; (4) Clinically significant chronic blood system diseases, or severe respiratory or digestive diseases; (5) Patients with a history of radical prostatectomy, spinal cord injury, pelvic (prostate, bladder, bowel) and genital injuries or a history of surgery or radiotherapy in the past; (6) Recovering from cancer or undergoing radiotherapy to the pelvic area in the past year; (7) Use of anti-androgens and androgen drugs; coagulation dysfunction and use of anticoagulants (such as Coumadin) and other drug-induced ED; (8) Those who supplemented probiotic-related preparations and received antibiotic treatment within 2 weeks before enrollment, including but not limited to other probiotic supplements, vitamin C, vitamin E, yogurt and other products; (9) Those who have neurological or mental illness and are unable or unwilling to cooperate; (10) Those who have a childbirth plan during the trial and within 3 months after the end of the trial; (11) Have a history of drug abuse, or a history of alcohol abuse within the past 6 months, or other conditions that, according to the researcher's judgment, reduce the possibility of enrollment or complicate enrollment (alcohol abuse is defined as the amount of alcohol consumed per week) >14 alcohol units, a 350ml bottle of beer, 120ml wine or 30ml of spirits with an alcohol content of 40% is one alcohol unit); (12) Those who have participated in any other clinical research of medical devices or drugs in the past 3 months; (13) Patients considered by other investigators to be unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Index of Erectile Function Questionnaire Score (IIEF-5); | — |
Secondary
| Measure | Time frame |
|---|---|
| AMS Questionnaire Score;EHS—erectile hardness score;International Prostate Symptom Score (I-PSS);Chronic Prostatitis Symptom Index (NIH-CPSI); | — |
Countries
China
Contacts
Public ContactShujie Xia
Shanghai General Hospital
Outcome results
None listed