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

NCT05890235 | Completed Phase 4

• 1 other identifier: NMT18016S
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief Summary

• 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:

Conditions

Chronic Prostatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Treatment for 8 weeks

Secondary Outcomes (3)

• NIH-CPSI total score, pain score, urinary score and quality of life score

  Treatment for 4 weeks

• NIH-CPSI total score, pain score, urinary score and quality of life score

  Treatment for 8 weeks

• Response rate

  Treatment for 4 & 8 weeks

Study Arms (3)

Ningmitai Capsule group

EXPERIMENTAL

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

Drug: Ningmitai Capsule

Tamsulosin Hydrochloride Sustained-release Capsules group

ACTIVE COMPARATOR

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

Drug: Tamsulosin Hydrochloride

Combined group

ACTIVE COMPARATOR

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

Interventions

Ningmitai Capsule DRUG

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

Combined group; Ningmitai Capsule group

Tamsulosin Hydrochloride DRUG

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

Combined group; Tamsulosin Hydrochloride Sustained-release Capsules group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xintian Pharmaceutical: lead

Study Sites (1)

The first affiliated hospital of Anhui medical university

Hefei, Anhui, China

Location

Related Publications (1)

• Gao J, Zhang Y, Du J, Liu Q, Cheng Y, Yang W, Wang D, Wang W, Zheng L, Wang D, Wu L, Jiang X, Men Q, Liang C, Zhang X. Ningmitai capsule in patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, prospective, randomized, parallel, positive-controlled study. Front Pharmacol. 2025 Dec 3;16:1667819. doi: 10.3389/fphar.2025.1667819. eCollection 2025.

  PMID: 41415574 DERIVED

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Zhongguo Chen, MD

  employee

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 6, 2023
• Study Start: November 16, 2018
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: June 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)