Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
- Conditions
- Chronic Prostatitis With Chronic Pelvic Pain SyndromeErectile Dysfunction
- Interventions
- Registration Number
- NCT06064448
- Lead Sponsor
- Xintian Pharmaceutical
- 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.
- Detailed Description
Sample size: 214
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 254
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Western Medicine Section (Sildenafil) 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. Traditional Chinese medicine group (Ningmitai capsule) 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. Combined group (Ningmitai capsule + sildenafil) Ningbitai 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
Trial Locations
- Locations (1)
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China