ClinicalTrials.gg
Sign In
CompletedNCT06159114Updated Jul 27, 2026

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

A Phase 4 interventional study of Ningmitai capsule and Celecoxib capsule in Chronic Prostatitis, sponsored by Xintian Pharmaceutical. Completed at 1 site in China. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Xintian Pharmaceutical · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

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 Principal investigator：Zhou Huiliang Main research units：The First Affiliated Hospital of Fujian Medical University Clinical trial start and end dates：2023/07/01-2025/12/31 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.

Study type: Interventional study Total sample size:240

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.

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.

Interventions:

  1. Ningmitai group
  2. Celecoxib group
  3. Combination group
Read the detailed description

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 Principal investigator：Zhou Huiliang Main research units：The First Affiliated Hospital of Fujian Medical University Clinical trial start and end dates：2023/07/01-2025/12/31 Objective: To evaluate whether using Ningmitai capsule(NMT) alone or combined with Celecoxib for 6 weeks is more effective than Celecoxib in improving symptoms especially pain of CP/CPPS patients.

Study type: Interventional study Total sample size: 240

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 and agree to sign an informed consent form.

Exclusion criteria:

  1. 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;
  2. Patients who have received prostate surgery and treatment such as TURP, TUIP, open prostatectomy, biofeedback therapy, hyperthermia, ablation, prostate cryotherapy, transperineal extracorporeal shock wave therapy, prostate injection therapy, transurethral prostate perfusion therapy, or bladder surgery such as bladder neck incision;
  3. Urine WBC ≥ 5 /HP, urinary system infection within 3 months;
  4. Pelvic pain and voiding dysfunction caused by non-prostatitis factors, such as benign prostatic hyperplasia, diseases of testis, epididymis and spermatic cord, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumor, prostate cancer, anorectal disease, lumbar disease, central and peripheral neuropathy;
  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 indicators, such as ALT and AST ≥ 1.5 times the upper limit of reference value, creatinine (SCR) > the upper limit of reference value;
  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 (blind, deaf, mute, intellectual disability, etc.), psychiatric patients;
  11. Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator, such as frequent changes in the working environment that are likely to cause loss to follow-up;
  12. Participating in other clinical trials;
  13. Considered unsuitable for enrollment by the investigator.

Interventions:

  1. Ningmitai group Orally administered Ningmitai capsule and Celecoxib placebo after meals for 6 weeks.

    Ningmitai capsule: 0.38 g/capsule, tid, 4 capsules each time; Celecoxib placebo: 0.2 g/capsule, qd，1 capsule each time. Sample size: 80

  2. Celecoxib group Orally administered Celecoxib capsule and Ningmitai placebo after meals for 6 weeks.

    Celecoxib capsule: 0.2 g/capsule, qd，1 capsule each time; Ningmitai placebo: 0.38 g/capsule, tid, 4 capsules each time. Sample size: 80

  3. Combination group Orally administered Ningmitai capsule and Celecoxib capsule after meals for 6 weeks.

Ningmitai capsule: 0.38 g/capsule, tid, 4 capsules each time; Celecoxib capsule: 0.2 g/capsule, qd，1 capsule each time. Sample size: 80 Treatment cycle：6 weeks. the trial treatment began on the day of randomization. Visiting nodes：① before treatment (-2 weeks to 0 days), ②2 weeks of treatment (14 ± 2 days), ③ 4 weeks of treatment (28 ± 5 days).④ 6 weeks of treatment（42 ± 7 days). ⑤week 8 (2 weeks after treatment cessation, 56 ± 7 days).

Countries of recruitment and research settings:

Country:China Province:Fujian Institutions (hospitals): The First Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Xiamen University.

Recruiting status: Not yet recruiting Randomization Procedure:In this study, the research center was used as the stratification factor of random assignment. Subjects were randomly assigned (1:1:1) to NMT group, Celecoxib group and combination group according to the random allocation table (subject random code) simulated by SAS 9.2 software. Subjects' random numbers cannot be reused by other subjects, whether they are using the study drug or not, or the study is terminated for any reason.

Sign the informed consent: Yes. Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:In this study, case report form (CRF) was used to collect and manage research data. The sponsor or designated person is responsible for data management of the study, including data quality control. The workflow of data management includes data entry, data verification and query, medical coding, data audit, database locking, data export and transmission, data and data management file archiving, etc.

02

Conditions studied

  • Chronic Prostatitis

Browse trials for

Keywords

  • NIH-CPSI
  • pain score
  • CP/CPPS
03

In context

Prostatitis

88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.

This study's enrollment of 242 is above the median of 60 across 73 interventional studies indexed under Prostatitis.

Browse Prostatitis studies →

Lead sponsor

Xintian Pharmaceutical is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and agree to sign an form.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Patients who have received prostate surgery and treatment such as TURP, TUIP, open prostatectomy, biofeedback therapy, hyperthermia, ablation, prostate cryotherapy, transperineal extracorporeal shock wave therapy, prostate injection therapy, transurethral prostate perfusion therapy, or bladder surgery such as bladder neck incision;
  3. Urine WBC ≥ 5 /HP, urinary system infection within 3 months;
  4. Pelvic pain and voiding dysfunction caused by non-prostatitis factors, such as benign prostatic hyperplasia, diseases of testis, epididymis and spermatic cord, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumor, prostate cancer, anorectal disease, lumbar disease, central and peripheral neuropathy;
  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 indicators, such as and AST ≥ 1.5 times the upper limit of reference value, creatinine (SCR) > the upper limit of reference value;
  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 (blind, deaf, mute, intellectual disability, etc.), psychiatric patients;
  11. Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator, such as frequent changes in the working environment that are likely to cause loss to follow-up;
  12. Participating in other clinical trials;
  13. Considered unsuitable for enrollment by the investigator.
Terms in these criteria, in plain language(2)

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.

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.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    Ningmitai Capsule Group

    Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules and celexcoib placebo, 0.2 g/ capsule, 1 capsule, qd each time, after meals, for 6 weeks.

    Drug: Ningmitai capsule · Drug: Celecoxib placebo

  • Active comparator
    Celecoxib Capsule Group

    Patients take celexcoib capsule, 0.2 g/capsule, qd, 1 capsule and Ningmitai placebo, 0.38 g/ capsule, 4 cpsule, tid each time, after meals, for 6 weeks.

    Drug: Celecoxib capsule · Drug: Ningmitai placebo

  • Experimental
    Combined Group

    Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules and celexcoib capsule, 0.2 g/ capsule, 1 capsule, qd each time, after meals, for 6 weeks.

    Drug: Ningmitai capsule · Drug: Celecoxib capsule

Interventions

  • DrugNingmitai capsule

    Ningmitai capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.

  • DrugCelecoxib capsule

    Celecoxib is one of NSAIDs recommended by the CUA Prostatitis Guidelines for alleviating pain symptoms in CP/CPPS patients. The instruction of Celecoxib capsule is 1 capsule at a time, 1 time a day.

  • DrugNingmitai placebo

    Ningmitai placebo, a look-alike substance that contains no active drug, similar to Ningmitai capsule in color, smell, taste, shape, texture and other characteristics, 0.38g/ capsule.

  • DrugCelecoxib placebo

    Celecoxib placebo, a look-alike substance that contains no active drug, similar to Celecoxib capsule in color, smell, taste, shape, texture and other characteristics, 0.2g/ capsule.

06

What researchers measure

Primary outcomes

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

    The change of NIH-CPSI pain score from baseline to 6 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.

    Time frame: Treatment for 6 weeks

Secondary outcomes

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

    The change of NIH-CPSI pain score from baseline to 2, 4, 8 weeks，respectively. 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: Week 2, 4, 8

  2. Total score, urinary score and quality of life score of the National Institutes of Health Chronic Prostatitis Symptom Index

    The change of NIH-CPSI total score, urinary score and quality of life score from baseline to 2, 4, 6, 8 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.

    Time frame: Week 2, 4, 6, 8

  3. The scores of questions 1~4 of the National Institutes of Health Chronic Prostatitis Symptom Index

    The change of scores of NIH-CPSI questions 1\~4 from baseline to 2 weeks. Questions 1\~4 (0\~21 points) evaluates the location, frequency and severity of pain. The higher the score, the more serious the pain symptoms of chronic prostatitis.

    Time frame: Treatment for 2 weeks

  4. The scores of questions 1~4 of the National Institutes of Health Chronic Prostatitis Symptom Index

    The change of scores of NIH-CPSI questions 1\~4 from baseline to 4 weeks. Questions 1\~4 (0\~21 points) evaluates the location, frequency and severity of pain. The higher the score, the more serious the pain symptoms of chronic prostatitis.

    Time frame: Treatment for 4 weeks

  5. The scores of questions 1~4 in the National Institutes of Health Chronic Prostatitis Symptom Index

    The change of scores of questions 1\~4 in NIH-CPSI from baseline to 6 weeks. Questions 1\~4 (0\~21 points) evaluates the location, frequency and severity of pain. The higher the score, the more serious the pain symptoms of chronic prostatitis.

    Time frame: Treatment for 6 weeks

  6. Response rate

    The response rate is defined as a decrease of at least 2 points in the NIH-CPSI pain score and at least 4 points in the NIH-CPSI total score, respectively.

    Time frame: Treatment for 2 weeks, 4 weeks and 6 weeks

07

Study locations

1 site
  • The First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06159114
Lead sponsor
Xintian Pharmaceutical
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Dec 19, 2023
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Jul 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Celecoxib

Other studies in this condition

Prostatitis →

Other studies from this sponsor

Xintian Pharmaceutical

Start the discussion