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

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

Conditions

• Chronic Prostatitis

Interventions

DRUG

Ningmitai Capsule

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.

DRUG

Tamsulosin Hydrochloride

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.

Sponsors & Collaborators

• Xintian Pharmaceutical

  lead INDUSTRY

Principal Investigators

• Zhongguo Chen, MD · employee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-16

Primary Completion

2022-07-10

Completion

2022-07-10

Countries

• China

Study Locations