Title
Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome
Phase
Phase 3Lead Sponsor
Justus Liebig University GiessenStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Prostatitis Chronic Pelvic Pain SyndromeIntervention/Treatment
cernilton ...Study Participants
139In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. The purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory CP-CPPS (National Institutes of Health (NIH) type IIIA). Participants were randomized to Cernilton or placebo for 12 weeks and were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) individual domains and total score, the number of leukocytes in post prostatic massage urine, the International Prostate Symptom Score (IPSS) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 weeks.
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks.
Oral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
Inclusion Criteria: men between 18 and 65 years symptoms of pelvic pain for at least 3 months during the 6 months before study entry a score in the pain domain of the German validated version of the NIH chronic prostatitis symptom index (NIH-CPSI) of 7 or higher leukocytes of 10 or more in post prostate massage urine Exclusion Criteria: urinary tract infection acute bacterial or chronic bacterial prostatitis history of urethritis with discharge 4 weeks prior to study entry a history of epididymitis or sexually transmitted disease residual urine volume of more than 50 mL due to bladder outlet obstruction indication for or history of prostate surgery including prostate biopsy treatment with phytotherapeutic agents alpha-blocker agents or antimicrobial substances with prostatic penetration 4 weeks prior to study entry treatment with agents influencing intraprostatic hormone metabolism 6 months prior to study entry
| Event Type | Organ System | Event Term |
|---|
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
Decrease of score points. Decrease of leucocytes in urine.
