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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:
â‘ Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.
â‘¡ 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.
â‘¢ 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.
Sample size: 214
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deng Chunhua, Doctor | First Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 671013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40365426 | Derived | 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. |
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| 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. |
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| 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. |
|
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| 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 |
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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