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

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

Conditions

• Chronic Prostatitis

Interventions

DRUG

Ningmitai 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.

DRUG

Celecoxib 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.

DRUG

Ningmitai 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.

DRUG

Celecoxib 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.

Sponsors & Collaborators

• Xintian Pharmaceutical

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-19

Primary Completion

2025-01-31

Completion

2025-01-31

Countries

• China

Study Locations