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

NCT06064448 | Completed Phase 4

• 1 other identifier: NMT18031S
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Erectile Dysfunction

Keywords

Ningmitai capsule; Sildenafil; Chronic prostatitis/chronic pelvic pain syndrome; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• The response rate of patients at 4 weeks of treatment.

  The response rate is defined as the proportion of patients whose NIH-CPSI pain score decreased by at least 4 points and IIEF-5 score or EHS score increased at 4 weeks of treatment.

  Treatment for 4 weeks

Secondary Outcomes (3)

• NIH-CPSI sub-score and its change value compared with baseline period at 2 weeks and 4 weeks of treatment

  Treatment for 2 and 4 weeks

• At 2 and 4 weeks of treatment, IIEF-5 score and its change compared with baseline.

  Treatment for 2 and 4 weeks

• The evaluation grade of EHS of patients at 2 weeks and 4 weeks of treatment

  Treatment for 2 and 4 weeks

Study Arms (3)

Western Medicine Section (Sildenafil)

ACTIVE COMPARATOR

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.

Drug: Sildenafil

Traditional Chinese medicine group (Ningmitai capsule)

EXPERIMENTAL

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.

Drug: Ningmitai capsule

Combined group (Ningmitai capsule + sildenafil)

EXPERIMENTAL

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.

Drug: Ningbitai capsule + sildenafil

Interventions

Sildenafil DRUG

Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.

Also known as: Western Medicine Section

Western Medicine Section (Sildenafil)

Ningmitai capsule DRUG

The subjects took Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, after meals, and continued to treat for 4 weeks.

Also known as: Traditional Chinese medicine group

Traditional Chinese medicine group (Ningmitai capsule)

Ningbitai capsule + sildenafil DRUG

The subjects took Ningmitai capsule orally, 0.38 g/capsule, 3 times a day, 4 capsules each time, and took it after meals. Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken orally for 4 weeks.

Also known as: Combined group

Combined group (Ningmitai capsule + sildenafil)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xintian Pharmaceutical: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 671013, China

Location

Related Publications (1)

• Luo D, Guo J, Chen T, Liu G, Luo P, Deng Z, Tang YX, Liao Y, Deng C. The efficacy of combination therapy with Ningmitai capsule and sildenafil in men with chronic prostatitis/chronic pelvic pain syndrome and erectile dysfunction: a prospective, multicenter, randomized controlled trial. Sex Med. 2025 May 13;13(2):qfaf024. doi: 10.1093/sexmed/qfaf024. eCollection 2025 Apr.

  PMID: 40365426 DERIVED

MeSH Terms

Conditions

Prostatitis; Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Deng Chunhua, Doctor

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: March 19, 2019
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)