Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction

Guiyang Xintian Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Erectile Dysfunction

Treatments: Drug: Ningbitai capsule + sildenafil; Drug: Ningmitai capsule; Drug: Sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT06064448

NMT18031S

Details and patient eligibility

About

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.

Full description

Sample size: 214

Enrollment: 254 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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254 participants in 3 patient groups

Western Medicine Section (Sildenafil)

Active Comparator group

Description:

Sildenafil is an effective and commonly used oral PDE5 inhibitor in the treatment of ED. In this study, the subjects in the western medicine group will take sildenafil citrate orally, 25mg/capsule, once a night, one capsule each time for 4 weeks.

Treatment:

Drug: Sildenafil

Traditional Chinese medicine group (Ningmitai capsule)

Experimental group

Description:

Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of Urinary and reproductive system disease (eg. CP/CPPS, ED) in China for more than twenty years. In this study, the subjects took Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd., Sinopharm Zhunzi Z20025442), 0.38 g/capsule, 3 times a day, 4 capsules each time, and took it after meals for 4 weeks.

Treatment:

Drug: Ningmitai capsule

Combined group (Ningmitai capsule + sildenafil)

Experimental group

Description:

In this study, the subjects will take Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd., Sinopharm Zhunzi Z20025442), 0.38 g/capsule, 4 capsules each time three times a day, after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken orally for 4 weeks.

Treatment:

Drug: Ningbitai capsule + sildenafil