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

Sponsor

Xintian Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT06064448

Collaborator

(none)

254

Enrollment

Location

Arms

45.1

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Prostatitis/Chronic Pelvic Pain Syndrome With Erectile Dysfunction	Drug: Western Medicine Section (Sildenafil) Drug: Traditional Chinese medicine group (Ningmitai capsule) Drug: Combined group (Ningbitai capsule + sildenafil)	Phase 4

Detailed Description

Sample size: 214

Study Design

Study Type:

Interventional

Actual Enrollment :

254 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 19, 2019

Actual Primary Completion Date :

Dec 22, 2022

Actual Study Completion Date :

Dec 22, 2022

Arms and Interventions

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: Western Medicine Section (Sildenafil) Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.
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: Traditional Chinese medicine group (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.
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: Combined group (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.

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: Western Medicine Section (Sildenafil)

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

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: Traditional Chinese medicine group (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.

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: Combined group (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.

Outcome Measures

Primary Outcome Measures

The response rate of patients at 4 weeks of treatment. [Treatment for 4 weeks]
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.

Secondary Outcome Measures

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]
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.
At 2 and 4 weeks of treatment, IIEF-5 score and its change compared with baseline. [Treatment for 2 and 4 weeks]
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.
The evaluation grade of EHS of patients at 2 weeks and 4 weeks of treatment [Treatment for 2 and 4 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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