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Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Primary Purpose

Chronic Prostatitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ningmitai Capsule
Tamsulosin Hydrochloride
Sponsored by
Xintian Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Aged 18-60 years old male patients; 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. Clinical diagnosis: type III prostatitis. Exclusion Criteria: Use of any antibiotics and 1 receptor blockers in the past two weeks; Suffering from seminal vesiculitis, epididymitis, varicocele and prostate, bladder, urethra and other tumors and other diseases affecting bladder function; 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; Patients with severe cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases and mental illness; Known to be allergic to Ningmitai capsule or some of its components; Involuntary, unable to cooperate with the completion of the study.

Sites / Locations

  • The first affiliated hospital of Anhui medical university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Ningmitai Capsule group

Tamsulosin Hydrochloride Sustained-release Capsules group

Combined group

Arm Description

Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.

Patients take Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks and Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.

Outcomes

Primary Outcome Measures

The National Institutes of Health chronic prostatitis symptom index total score
the change of NIH-CPSI total score from baseline to 8 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.

Secondary Outcome Measures

NIH-CPSI total score, pain score, urinary score and quality of life score
The changes of NIH-CPSI total score, pain score, urinary score and quality of life score from baseline to 4 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.
NIH-CPSI total score, pain score, urinary score and quality of life score
The changes of NIH-CPSI pain score, urinary score and quality of life score from baseline to 8 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.
Response rate
The response rate is defined as a decrease of at least 25% in the NIH-CPSI total score and pain score, respectively

Full Information

First Posted
May 23, 2023
Last Updated
June 1, 2023
Sponsor
Xintian Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05890235
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
July 10, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xintian Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 Version number/date:1.0 /2018-6-24 Principal investigator:Zhang Xiansheng Main research units:The first affiliated hospital of Anhui medical university clinical medical research ethics committee Clinical trial start and end dates:2018-10-1-2022-12-31 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 . Study type:Interventional study Total sample size:300 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. 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
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 Version number/date:1.0 /2018-6-24 Principal investigator:Zhang Xiansheng Main research units:The first affiliated hospital of Anhui medical university clinical medical research ethics committee Clinical trial start and end dates:2018-10-1-2022-12-31 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 . Study type:Interventional study Total sample size:300 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ningmitai Capsule group
Arm Type
Experimental
Arm Description
Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.
Arm Title
Tamsulosin Hydrochloride Sustained-release Capsules group
Arm Type
Active Comparator
Arm Description
Patients take Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.
Arm Title
Combined group
Arm Type
Active Comparator
Arm Description
Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks and Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Ningmitai Capsule
Other Intervention Name(s)
Ningmitai
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin Hydrochloride
Other Intervention Name(s)
Tamsulosin
Intervention Description
Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.
Primary Outcome Measure Information:
Title
The National Institutes of Health chronic prostatitis symptom index total score
Description
the change of NIH-CPSI total score from baseline to 8 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.
Time Frame
Treatment for 8 weeks
Secondary Outcome Measure Information:
Title
NIH-CPSI total score, pain score, urinary score and quality of life score
Description
The changes of NIH-CPSI total score, pain score, urinary score and quality of life score from baseline to 4 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.
Time Frame
Treatment for 4 weeks
Title
NIH-CPSI total score, pain score, urinary score and quality of life score
Description
The changes of NIH-CPSI pain score, urinary score and quality of life score from baseline to 8 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.
Time Frame
Treatment for 8 weeks
Title
Response rate
Description
The response rate is defined as a decrease of at least 25% in the NIH-CPSI total score and pain score, respectively
Time Frame
Treatment for 4 & 8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-60 years old male patients; 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. Clinical diagnosis: type III prostatitis. Exclusion Criteria: Use of any antibiotics and 1 receptor blockers in the past two weeks; Suffering from seminal vesiculitis, epididymitis, varicocele and prostate, bladder, urethra and other tumors and other diseases affecting bladder function; 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; Patients with severe cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases and mental illness; Known to be allergic to Ningmitai capsule or some of its components; Involuntary, unable to cooperate with the completion of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongguo Chen, MD
Organizational Affiliation
employee
Official's Role
Study Chair
Facility Information:
Facility Name
The first affiliated hospital of Anhui medical university
City
Hefei
State/Province
Anhui
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

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