Status:
COMPLETED
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Lead Sponsor:
Xintian Pharmaceutical
Conditions:
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Erectile Dysfunction
Eligibility:
MALE
20-50 years
Phase:
PHASE4
Brief Summary
Objective: The purpose of this study was to evaluate the clinical efficacy and safety of Ningmitai capsule alone or in combination with sildenafil compared with sildenafil alone in the treatment of CP...
Detailed Description
Sample size: 214
Eligibility Criteria
Inclusion
- Male patients aged 20-50 years;
- Have a fixed sexual partner and have a normal sexual life;
- Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4), or accompanied by lower urinary tract symptoms (micturition score \> 4), lasting more than 3 months;
- Secondary patients with erectile dysfunction after normal erection or sexual intercourse, and IIEF-5 ≤ 21 points;
- It accords with the main symptoms of damp-heat stagnation syndrome in traditional Chinese medicine;
- Volunteer subjects and agree to sign informed consent.
Exclusion
- Those who use any antibiotics, α-receptor blockers, PDE5 inhibitors and androgens within one week;
- Patients with varicocele or tumors in prostate, bladder and urethra;
- Have received TURP, TUIP, bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia;
- Patients with severe organic ED, drug-induced and traumatic ED, abnormal development of external genitalia or abnormal sex hormone level;
- Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis;
- Those who are known to be allergic to the drugs tested in this study or some of their components
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT06064448
Start Date
March 19 2019
End Date
December 22 2022
Last Update
October 12 2023
Active Locations (1)
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1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 671013