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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064448
• Other study ID #: NMT18031S
• Status: Completed
• Phase: Phase 4
• Start date: March 19, 2019
• Est. completion date: December 22, 2022

Study information

• Verified date: September 2023
• Source: Xintian Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Sample size: 214

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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, a-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

Related Conditions & MeSH terms

• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Erectile Dysfunction
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Xintian Pharmaceutical

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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