A Phase 4 interventional study of Sildenafil and Ningmitai capsule in Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Erectile Dysfunction, sponsored by Xintian Pharmaceutical. Completed at 1 site in China. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by Xintian Pharmaceutical · Phase 4, Interventional, and Treatment
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.
Sample size: 214
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 254 is above the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Xintian Pharmaceutical is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.
Also known as: Western Medicine Section
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.
Also known as: Traditional Chinese medicine group
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.
Also known as: Combined group
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.
Time frame: Treatment for 4 weeks
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.
Time frame: 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.
Time frame: 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).
Time frame: Treatment for 2 and 4 weeks
Plan to share: No
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Ran from Mar 2019 to primary completion in Dec 2022, 45 months.
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Xintian Pharmaceutical