Clinical trial NCT05890235: Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Official title: Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A Prospective, Randomized, Positive Drug-controlled, Multicenter Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Prostatitis
Lead sponsor: Xintian Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 323
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study
2. Version number/date：1.0 /2018-6-24
3. Principal investigator：Zhang Xiansheng
4. Main research units：The first affiliated hospital of Anhui medical university clinical medical research ethics committee
5. Clinical trial start and end dates：2018-10-1-2022-12-31
6. Objective: To observe whether Ningmitai capsule(NMT) alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CP/CPPS .
7. Study type:Interventional study
8. Total sample size:300
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 Diagnosed as type III prostatitis.

   Exclusion criteria:
   * Use any antibiotics and α1 receptor blockers in the past two weeks; ② Suffering from seminal vesiculitis, epididymitis, varicocele, tumors in prostate, bladder and urethra and other diseases affecting bladder function;

     * Have received transurethral resection of the prostate(TURP), transurethral incision of the prostate (TUIP), bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy;

       * Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis; ⑤ Patients who are allergic to NMT or some of its components; ⑥ Patients who are involuntarily unable to cooperate with the completion of the test.
10. Interventions:

1. NMT group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.

Sample size:100 2. Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100 3.Combination group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100

Detailed description: 1. Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study
2. Version number/date：1.0 /2018-6-24
3. Principal investigator：Zhang Xiansheng
4. Main research units：The first affiliated hospital of Anhui medical university clinical medical research ethics committee
5. Clinical trial start and end dates：2018-10-1-2022-12-31
6. Objective: To observe whether Ningmitai capsule(NMT) alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CP/CPPS .
7. Study type:Interventional study
8. Total sample size:300
9. Interventions:

1. NMT group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.

Sample size:100 2. Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100 3.Combination group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Sample size:100

10、Treatment cycle：8 weeks. the trial treatment began on the day of randomization.

11、Visiting nodes：① before treatment (-2 weeks to 0 days), ②4 weeks of treatment (28 ± 10 days), ③ 8 weeks of treatment (56 ± 14 days).

12、Countries of recruitment and research settings: Country:China Province:Anhui Institution(hospital):The first affiliated hospital of Anhui medical university Level of the institution:Tertiary A

13、Recruiting status:Completed Participant age:18 years Participant age:60 years Gender: Male

14、Randomization Procedure:In this study, the research center was used as the stratification factoror random assignment. Subjects were randomly assigned (1:1:1) to Tamsulosin group, NMT 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.

15、Sign the informed consent: Yes

16、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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-60 years old male patients;
2. Patients with long-term, repeated pelvic discomfort or pain (NIH-CPSI pain score 4), lasting more than 3 months, may be accompanied by varying degrees of voiding symptoms and sexual dysfunction.
3. Clinical diagnosis: type III prostatitis.

Exclusion Criteria:

1. Use of any antibiotics and 1 receptor blockers in the past two weeks;
2. Suffering from seminal vesiculitis, epididymitis, varicocele and prostate, bladder, urethra and other tumors and other diseases affecting bladder function;
3. Have received TURP, TUIP, internal cystotomy, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia;
4. Patients with severe cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases and mental illness;
5. Known to be allergic to Ningmitai capsule or some of its components;
6. Involuntary, unable to cooperate with the completion of the study.

Primary outcomes:
measure: The National Institutes of Health chronic prostatitis symptom index total score
timeFrame: Treatment for 8 weeks
Secondary outcomes:
measure: NIH-CPSI total score, pain score, urinary score and quality of life score
timeFrame: Treatment for 4 weeks
measure: NIH-CPSI total score, pain score, urinary score and quality of life score
timeFrame: Treatment for 8 weeks
measure: Response rate
timeFrame: Treatment for 4 & 8 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The first affiliated hospital of Anhui medical university
state: Anhui
Study officials:
affiliation: employee
name: Zhongguo Chen, MD
role: STUDY_CHAIR
References: