Ningmitai capsule in patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, prospective, randomized, parallel, positive-controlled study.

Background: CP/CPPS is characterized by pain, the primary symptom, which significantly affects QoL and disrupts lower urinary tract function. Conventional monotherapies are often ineffective, necessitating multimodal treatments targeting key symptoms. Methods: This multicenter, prospective, randomized, parallel, positive-controlled trial enrolled 323 men aged 18-60 years with CP/CPPS across 14 centers in China. Participants were randomly assigned to three groups: tamsulosin 0.2 mg daily, Ningmitai capsule (NMT) 1.52 g thrice daily, or a combination of both, for 8 weeks. The primary endpoint was the change in the total NIH-CPSI score from baseline to week 8. Secondary endpoints included changes in pain, urinary, QoL subdomains, the percentage of patients achieving a ≥25% reduction in NIH-CPSI total score, and pain scores. Safety was monitored through adverse events and liver function tests. Results: Of the 323 patients, 108 received tamsulosin, 109 NMT, and 106 combination therapy. After 8 weeks, both NMT and combination therapy demonstrated significantly greater reductions in total NIH-CPSI scores compared to tamsulosin (-11.44 vs. -8.58, Conclusion: NMT demonstrated superior efficacy over tamsulosin in reducing pain and improving QoL in CP/CPPS patients. Combination therapy provided enhanced symptom relief, particularly in micturition and QoL domains, supporting a multimodal approach for more effective CP/CPPS management. These findings validate NMT as a promising treatment, either alone or in combination, for CP/CPPS. Further long-term studies are needed to optimize its use. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT05890235.