A Phase 4 interventional study of Ningmitai Capsule and Tamsulosin Hydrochloride in Chronic Prostatitis, sponsored by Xintian Pharmaceutical. Completed at 1 site in China. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by Xintian Pharmaceutical · Phase 4, Interventional, and Treatment
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;
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
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.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 323 is above the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Xintian Pharmaceutical is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients take Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.
Drug: Ningmitai Capsule
Patients take Tamsulosin Hydrochloride Sustained-release Capsules ,0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks.
Drug: Tamsulosin Hydrochloride
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.
Drug: Ningmitai Capsule · Drug: Tamsulosin Hydrochloride
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.
Also known as: Ningmitai
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.
Also known as: Tamsulosin
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.
Time frame: Treatment for 8 weeks
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.
Time frame: Treatment for 4 weeks
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.
Time frame: Treatment for 8 weeks
Response rate
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2018 to primary completion in Jul 2022, 43 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xintian Pharmaceutical