Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)

Study Overview
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Brief Summary
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In 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.

Detailed Description
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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.

Official Title
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Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome

Conditions
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Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Drug: Cernilton
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cernilton<br>Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS) | Drug: Cernilton<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS) | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21. | 0, 6, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine. | Decrease of score points. Decrease of leucocytes in urine. | 0, 6, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic prostatitis symptom index, male, inflammatory, CP-CPPS, Cernilton, pelvic pain, symptoms