CompletedPhase 4

Efficacy and Safety of Ningmitai Capsule Alone or Combined With Celecoxib in the Treatment of CP/CPPS

China246 participantsStarted 2023-12-19

Plain-language summary

1. Clinical trial title：Efficacy and safety of Ningmitai capsule alone or combined with celecoxib in the treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): A prospective, randomized, double-blind, multicenter clinical study 2. Version number/date：1.1/2023-10-09 3. Principal investigator：Zhou Huiliang 4. Main research units：The First Affiliated Hospital of Fujian Medical University 5. Clinical trial start and end dates：2023/07/01-2025/12/31 6. Objective: To evaluate whether Ningmitai capsule(NMT) alone or combined with Celecoxib for 6 weeks is more effective than Celecoxib in improving pain symptoms of CP/CPPS patients. 7. Study type: Interventional study 8. Total sample size:240 9. Inclusion criteria: （1）Age: male patients aged 18-60 years; （2）Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4 points), lasting more than 3 months, may be accompanied by different degrees of urination symptoms and sexual dysfunction; （3）Negative bacterial in urine before and after prostate massage; （4）Voluntarily participate in the trial. 10、Exclusion criteria: 1. Utilize any drugs for the treatment of chronic prostatitis in the past 2 weeks; 2. Patients who have received prostate surgery and treatment; 3. Urine WBC ≥ 5/HP, urinary system infection within 12 months, and effective antibiotic treatment in the early stage; 4. Pelvic pain and voiding dysfunction caused by non-prostatitis factors. 5. Suffering from serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease or other serious diseases such as tumors or AIDS; 6. Significant adverse events in clinical or laboratory examination. 7. Allergic to the components of the test drugs or sulfa; 8. Previous active peptic ulcer / bleeding; 9. A birth plan within the past 8 months; 10. Legally disabled patients or psychiatric patients; 11. Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the possibility of enrollment； 12. Participating in other clinical trials; 13. Considered unsuitable for enrollment by the investigator. 11、Interventions: （1）Ningmitai group （2）Celecoxib group （3）Combination group

Who can participate

Age range

18 Years – 60 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: male patients aged 18-60 years;
. Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4 points), lasting more than 3 months, may be accompanied by different degrees of urination symptoms and sexual dysfunction;
. Negative bacterial in urine before and after prostate massage;
. Voluntarily participate in the trial and agree to sign an informed consent form.

Exclusion criteria

. Use any non-steroidal anti-inflammatory drugs，α receptor blockers，antibiotics, PDE5 inhibitors or other traditional Chinese medicines or botanicals for the treatment of prostatitis in the past 2 weeks; those who are using drugs for the treatment of prostatitis need to stop the drug for 2 weeks before the clinical trial;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain score of the National Institutes of Health Chronic Prostatitis Symptom Index

Timeframe: Treatment for 6 weeks

Trial details

NCT IDNCT06159114

SponsorXintian Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Chronic Prostatitis trials