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

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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Drug: Sildenafil; Drug: Ningmitai capsule; Drug: Ningbitai capsule + sildenafil

Detailed Description

Sample size: 214

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 671013
      • The First Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Western Medicine Section (Sildenafil); 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; Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.; Other Names: Western Medicine Section
Experimental: Traditional Chinese medicine group (Ningmitai capsule); 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; 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.; Other Names: Traditional Chinese medicine group
Experimental: Combined group (Ningmitai capsule + sildenafil); 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; 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.; Other Names: Combined group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH-CPSI sub-score and its change value compared with baseline period at 2 weeks and 4 weeks of treatment	National Institutions of Health Chronic Prostatitis Symptom Index（NIH-CPSI，0~43 points） consists of three subscales. The first part is pain symptoms, which consists of questions 1~4 (0~21 points), and evaluates the location, frequency and severity of pain. The second part is urination symptoms, which consists of questions 5~6 (0 ~ 10 points), and evaluates the severity of incomplete urination and frequent urination; The third part is to evaluate the impact on the quality of life, which consists of questions 7~9 (0~12 points).The higher the score, the more serious the symptoms of chronic prostatitis.	Treatment for 2 and 4 weeks
At 2 and 4 weeks of treatment, IIEF-5 score and its change compared with baseline.	Change value = IIEF-5 score after treatment-baseline IIEF-5 score IIEF-5 contains five questions about erectile status, confidence in maintaining erection and satisfaction with sexual intercourse, and is widely used to diagnose ED, judge the severity of ED and evaluate the effectiveness of drug treatment for ED. Total score 25 points, the lower the score, the more serious the symptoms.	Treatment for 2 and 4 weeks
The evaluation grade of EHS of patients at 2 weeks and 4 weeks of treatment	Erectile hardness score (EHS) is a commonly used method to evaluate the severity of ED in clinic. They are divided into grade I (severe ED), grade II (moderate ED), grade III (mild ED) and grade IV (normal erectile function).	Treatment for 2 and 4 weeks

Collaborators and Investigators

• Sponsor: Xintian Pharmaceutical
• Investigators: Study Chair: Deng Chunhua, Doctor, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Sildenafil; Ningmitai capsule; Chronic prostatitis/chronic pelvic pain syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Prostatic Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Syndrome; Somatoform Disorders; Erectile Dysfunction; Pelvic Pain; Prostatitis; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: NMT18031S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No