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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Pain score of the National Institutes of Health Chronic Prostatitis Symptom Index
研究概览
简要总结
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:
- 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.
Exclusion criteria:
- Utilize any drugs for the treatment of chronic prostatitis in the past 2 weeks;
- Patients who have received prostate surgery and treatment;
- Urine WBC ≥ 5/HP, urinary system infection within 12 months, and effective antibiotic treatment in the early stage;
- Pelvic pain and voiding dysfunction caused by non-prostatitis factors.
- 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.
- 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 or psychiatric patients;
- Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the possibility of enrollment；
- Participating in other clinical trials;
- Considered unsuitable for enrollment by the investigator.
Interventions:
- Ningmitai group
- Celecoxib group
- Combination group
详细描述
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:
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Celecoxib placebo (Drug)
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.
干预措施: Celecoxib capsule (Drug)
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.
干预措施: Celecoxib capsule (Drug)
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.
干预措施: Ningmitai capsule (Drug)
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.
干预措施: Ningmitai placebo (Drug)
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.
干预措施: Ningmitai capsule (Drug)
结局指标
主要结局
Pain score of the National Institutes of Health Chronic Prostatitis Symptom Index
时间窗: Treatment for 6 weeks
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.
次要结局
- The scores of questions 1~4 of the National Institutes of Health Chronic Prostatitis Symptom Index(Treatment for 4 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 6 weeks)
- The scores of questions 1~4 in the National Institutes of Health Chronic Prostatitis Symptom Index(Treatment for 6 weeks)
- Response rate(Treatment for 2 weeks, 4 weeks and 8 weeks)
- Pain score of the National Institutes of Health Chronic Prostatitis Symptom Index(Week 2, 4, 8)
- Total score, urinary score and quality of life score of the National Institutes of Health Chronic Prostatitis Symptom Index(Week 2, 4, 6, 8)
- The scores of questions 1~4 of the National Institutes of Health Chronic Prostatitis Symptom Index(Treatment for 2 weeks)
- Response rate(Treatment for 2 weeks, 4 weeks and 6 weeks)