Clinical trial NCT06064448: Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Official title: A Prospective, Multicenter, Randomized, Parallel and Positive Drug-controlled Clinical Study of Ningbitai Capsule in the Treatment of Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Erectile Dysfunction
Keywords: Ningmitai capsule
Sildenafil
Chronic prostatitis/chronic pelvic pain syndrome
Erectile Dysfunction
Lead sponsor: Xintian Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 254
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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/CPPS with erectile dysfunction.

Study Design: A multicenter, prospective, randomized and positive drug-controlled clinical study design was adopted.

Interventions:

① Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.

② Chinese medicine group (Ningmitai capsule): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals for 4 weeks continuously.

③ Combination group (Ningmitai capsule + sildenafil): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken continuously for 4 weeks.

Detailed description: Sample size: 214

Eligibility criteria: Inclusion Criteria:

1. Male patients aged 20-50 years;
2. Have a fixed sexual partner and have a normal sexual life;
3. 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;
4. Secondary patients with erectile dysfunction after normal erection or sexual intercourse, and IIEF-5 ≤ 21 points;
5. It accords with the main symptoms of damp-heat stagnation syndrome in traditional Chinese medicine;
6. Volunteer subjects and agree to sign informed consent.

Exclusion Criteria:

1. Those who use any antibiotics, α-receptor blockers, PDE5 inhibitors and androgens within one week;
2. Patients with varicocele or tumors in prostate, bladder and urethra;
3. 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;
4. Patients with severe organic ED, drug-induced and traumatic ED, abnormal development of external genitalia or abnormal sex hormone level;
5. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis;
6. Those who are known to be allergic to the drugs tested in this study or some of their components

Primary outcomes:
measure: The response rate of patients at 4 weeks of treatment.
timeFrame: Treatment for 4 weeks
Secondary outcomes:
measure: NIH-CPSI sub-score and its change value compared with baseline period at 2 weeks and 4 weeks of treatment
timeFrame: Treatment for 2 and 4 weeks
measure: At 2 and 4 weeks of treatment, IIEF-5 score and its change compared with baseline.
timeFrame: Treatment for 2 and 4 weeks
measure: The evaluation grade of EHS of patients at 2 weeks and 4 weeks of treatment
timeFrame: Treatment for 2 and 4 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Deng Chunhua, Doctor
role: STUDY_CHAIR
References: