Chronic Prostatitis With Chronic Pelvic Pain SyndromePhase 4NCT06064448
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
A Phase 4 study testing Sildenafil, Ningmitai capsule and Ningbitai capsule + sildenafil in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Erectile Dysfunction, run by Xintian Pharmaceutical at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Erectile Dysfunction
- What is being tested?
- Sildenafil, Ningmitai capsule and Ningbitai capsule + sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2019to 22 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 671013
About this study
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
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.
Read more
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.
Read the detailed description
Sample size: 214
- Being tested
- Sildenafil, Ningmitai capsule, Ningbitai capsule + sildenafil
- Keywords
- Ningmitai capsule, Sildenafil, Chronic prostatitis/chronic pelvic pain syndrome, Erectile Dysfunction
- Medical subject headings
- Prostatitis, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Western Medicine Section
Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.
Ningmitai capsuleDrug
Also called Traditional Chinese medicine group
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 + sildenafilDrug
Also called Combined 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sildenafil |
| 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. Receives: Drug: Ningmitai capsule |
| 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. Receives: Drug: Ningbitai capsule + sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Treatment for 4 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Treatment for 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start19 Mar 2019
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Prostatitis With Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xintian Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deng Chunhua, Doctor, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064448
- Sponsor's protocol ID
- NMT18031S
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40365426
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06064448
- Acronym / sponsor ID
- NMT18031S
- Keywords
- Ningmitai capsule, Sildenafil, Chronic prostatitis/chronic pelvic pain syndrome, Erectile Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Xintian PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Western Medicine Section (Sildenafil) | Active comparator | Drug: SildenafilSildenafil 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 | Drug: Ningmitai capsuleNingmitai 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 | Drug: Ningbitai capsule + sildenafilIn 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: Western Medicine SectionSubjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks. | Drug | Western Medicine Section (Sildenafil) |
| Ningmitai capsuleAlso: Traditional Chinese medicine groupThe 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. | Drug | Traditional Chinese medicine group (Ningmitai capsule) |
| Ningbitai capsule + sildenafilAlso: Combined groupThe 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. | Drug | Combined group (Ningmitai capsule + sildenafil) |
Primary outcome
The response rate of patients at 4 weeks of treatment.
Time frame: 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.
3 secondary outcomes
NIH-CPSI sub-score and its change value compared with baseline period at 2 weeks and 4 weeks of treatment
Time frame: Treatment for 2 and 4 weeks
At 2 and 4 weeks of treatment, IIEF-5 score and its change compared with baseline.
Time frame: Treatment for 2 and 4 weeks
The evaluation grade of EHS of patients at 2 weeks and 4 weeks of treatment
Time frame: Treatment for 2 and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 40365426Luo 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Recruiting
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
Chronic Interstitial Cystitis, Bladder Pain Syndrome
Not yet recruiting
Acupuncture for Erectile Dysfunction
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions
Not yet recruiting
TECAR Therapy on Pain and Quality of Life in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Prostatitis
Recruiting
TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
Chronic Prostatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deng Chunhua, Doctor study chair
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil, Ningmitai capsule and Ningbitai capsule + sildenafil in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Erectile Dysfunction, run by Xintian Pharmaceutical at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate of patients at 4 weeks of treatment. (time frame: Treatment for 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.