Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890235
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2023-05-23
Brief Title:
Efficacy and Safety of Ningmitai Capsule in Patients With Chronic ProstatitisChronic Pelvic Pain Syndrome
Sponsor:
Xintian Pharmaceutical
Organization:
Xintian Pharmaceutical
Study Overview
Official Title:
Efficacy and Safety of Ningmitai Capsule in Patients With Chronic ProstatitisChronic Pelvic Pain SyndromeA Prospective Randomized Positive Drug-controlled Multicenter Clinical Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Clinical trial titleEfficacy and safety of Ningmitai capsule in patients with Chronic ProstatitisChronic Pelvic Pain SyndromeA prospective randomized positive drug-controlled multicenter clinical study
2 Version numberdate10 2018-6-24
3 Principal investigatorZhang Xiansheng
4 Main research unitsThe first affiliated hospital of Anhui medical university clinical medical research ethics committee
5 Clinical trial start and end dates2018-10-1-2022-12-31
6 Objective To observe whether Ningmitai capsuleNMT alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CPCPPS
7 Study typeInterventional study
8 Total sample size300
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 prostateTURP transurethral incision of the prostate TUIP bladder neck incision transurethral hyperthermiaradiofrequency ablationballoon 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 038 gcapsule tid 4 capsules each time after meals for 8 weeks
Sample size100 2 Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 02 mgcapsule once daily 1 capsule each time for 8 weeks
Sample size100 3Combination group Oral Ningmitai capsule 038 gcapsule tid 4 capsules each time after meals for 8 weeksTamsulosin Hydrochloride Sustained-release Capsules were orally administered at 02 mgcapsule once daily 1 capsule each time for 8 weeks
Sample size100
2 Version numberdate10 2018-6-24
3 Principal investigatorZhang Xiansheng
4 Main research unitsThe first affiliated hospital of Anhui medical university clinical medical research ethics committee
5 Clinical trial start and end dates2018-10-1-2022-12-31
6 Objective To observe whether Ningmitai capsuleNMT alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CPCPPS
7 Study typeInterventional study
8 Total sample size300
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 prostateTURP transurethral incision of the prostate TUIP bladder neck incision transurethral hyperthermiaradiofrequency ablationballoon 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 038 gcapsule tid 4 capsules each time after meals for 8 weeks
Sample size100 2 Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 02 mgcapsule once daily 1 capsule each time for 8 weeks
Sample size100 3Combination group Oral Ningmitai capsule 038 gcapsule tid 4 capsules each time after meals for 8 weeksTamsulosin Hydrochloride Sustained-release Capsules were orally administered at 02 mgcapsule once daily 1 capsule each time for 8 weeks
Sample size100
Detailed Description:
1 Clinical trial titleEfficacy and safety of Ningmitai capsule in patients with Chronic ProstatitisChronic Pelvic Pain SyndromeA prospective randomized positive drug-controlled multicenter clinical study
2 Version numberdate10 2018-6-24
3 Principal investigatorZhang Xiansheng
4 Main research unitsThe first affiliated hospital of Anhui medical university clinical medical research ethics committee
5 Clinical trial start and end dates2018-10-1-2022-12-31
6 Objective To observe whether Ningmitai capsuleNMT alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CPCPPS
7 Study typeInterventional study
8 Total sample size300
9 Interventions
1 NMT group Oral Ningmitai capsule 038 gcapsule tid 4 capsules each time after meals for 8 weeks
Sample size100 2 Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 02 mgcapsule once daily 1 capsule each time for 8 weeks
Sample size100 3Combination group Oral Ningmitai capsule 038 gcapsule tid 4 capsules each time after meals for 8 weeksTamsulosin Hydrochloride Sustained-release Capsules were orally administered at 02 mgcapsule once daily 1 capsule each time for 8 weeks
Sample size100
10Treatment cycle8 weeks the trial treatment began on the day of randomization
11Visiting nodes① before treatment -2 weeks to 0 days ②4 weeks of treatment 28 10 days ③ 8 weeks of treatment 56 14 days
12Countries of recruitment and research settings CountryChina ProvinceAnhui InstitutionhospitalThe first affiliated hospital of Anhui medical university Level of the institutionTertiary A
13Recruiting statusCompleted Participant age18 years Participant age60 years Gender Male
14Randomization ProcedureIn this study the research center was used as the stratification factoror random assignment Subjects were randomly assigned 111 to Tamsulosin group NMT group and combination group according to the random allocation table subject random code simulated by SAS 92 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
15Sign the informed consent Yes
16Data collection and Management A standard data collection and management system include a CRF and an electronic data captureIn 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
2 Version numberdate10 2018-6-24
3 Principal investigatorZhang Xiansheng
4 Main research unitsThe first affiliated hospital of Anhui medical university clinical medical research ethics committee
5 Clinical trial start and end dates2018-10-1-2022-12-31
6 Objective To observe whether Ningmitai capsuleNMT alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CPCPPS
7 Study typeInterventional study
8 Total sample size300
9 Interventions
1 NMT group Oral Ningmitai capsule 038 gcapsule tid 4 capsules each time after meals for 8 weeks
Sample size100 2 Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 02 mgcapsule once daily 1 capsule each time for 8 weeks
Sample size100 3Combination group Oral Ningmitai capsule 038 gcapsule tid 4 capsules each time after meals for 8 weeksTamsulosin Hydrochloride Sustained-release Capsules were orally administered at 02 mgcapsule once daily 1 capsule each time for 8 weeks
Sample size100
10Treatment cycle8 weeks the trial treatment began on the day of randomization
11Visiting nodes① before treatment -2 weeks to 0 days ②4 weeks of treatment 28 10 days ③ 8 weeks of treatment 56 14 days
12Countries of recruitment and research settings CountryChina ProvinceAnhui InstitutionhospitalThe first affiliated hospital of Anhui medical university Level of the institutionTertiary A
13Recruiting statusCompleted Participant age18 years Participant age60 years Gender Male
14Randomization ProcedureIn this study the research center was used as the stratification factoror random assignment Subjects were randomly assigned 111 to Tamsulosin group NMT group and combination group according to the random allocation table subject random code simulated by SAS 92 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
15Sign the informed consent Yes
16Data collection and Management A standard data collection and management system include a CRF and an electronic data captureIn 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None