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

NCT06159114 | Completed Phase 4

• 1 other identifier: NM-23-A-006-YJ-006
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Version number/date：1.1/2023-10-09
3. 3.Principal investigator：Zhou Huiliang
4. 4.Main research units：The First Affiliated Hospital of Fujian Medical University
5. 5.Clinical trial start and end dates：2023/07/01-2025/12/31
6. 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. 7.Study type: Interventional study
8. 8.Total sample size:240
9. 9.Inclusion criteria:
10. 10.Utilize any drugs for the treatment of chronic prostatitis in the past 2 weeks;
11. 11.Patients who have received prostate surgery and treatment;
12. 12.Urine WBC ≥ 5/HP, urinary system infection within 12 months, and effective antibiotic treatment in the early stage;
13. 13.Pelvic pain and voiding dysfunction caused by non-prostatitis factors.
14. 14.Suffering from serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease or other serious diseases such as tumors or AIDS;
15. 15.Significant adverse events in clinical or laboratory examination.
16. 16.Allergic to the components of the test drugs or sulfa;
17. 17.Previous active peptic ulcer / bleeding;
18. 18.A birth plan within the past 8 months;
19. 19.Legally disabled patients or psychiatric patients;
20. 20.Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the possibility of enrollment；
21. 21.Participating in other clinical trials;
22. 22.Considered unsuitable for enrollment by the investigator. 11、Interventions:

Conditions

Chronic Prostatitis

Keywords

NIH-CPSI; pain score; CP/CPPS

Outcome Measures

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.

  Treatment for 6 weeks

Secondary Outcomes (9)

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

  Treatment for 2 weeks

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

  Treatment for 4 weeks

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

  Treatment for 2 weeks

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

  Treatment for 4 weeks

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

  Treatment for 6 weeks

Study Arms (3)

Ningmitai Capsule Group

EXPERIMENTAL

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

Celecoxib Capsule Group

ACTIVE COMPARATOR

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

Combined Group

EXPERIMENTAL

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

Ningmitai capsule DRUG

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.

Combined Group; Ningmitai Capsule Group

Celecoxib capsule DRUG

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.

Celecoxib Capsule Group; Combined Group

Ningmitai placebo DRUG

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.

Celecoxib Capsule Group

Celecoxib placebo DRUG

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.

Ningmitai Capsule Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Urine WBC ≥ 5 /HP, urinary system infection within 3 months;
• 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;
• Suffering from serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease or other serious diseases such as tumors or AIDS;
• 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;
• Allergic to the components of the test drugs or sulfa;
• Previous active peptic ulcer / bleeding;
• A birth plan within the past 8 months;
• Legally disabled patients (blind, deaf, mute, intellectual disability, etc.), psychiatric patients;
• 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;
• Participating in other clinical trials;
• Considered unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Xintian Pharmaceutical: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 6, 2023
• Study Start: December 19, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)