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

Phase 3CompletedNCT00919893

University of Giessen139 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

139

Conditions

Chronic Prostatitis Chronic Pelvic Pain Syndrome

Interventions

CerniltonDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Justus-Liebig-University

Giessen, Germany

Outcomes

Primary Outcomes

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.

Time frame: 0, 6, 12 weeks

Secondary Outcomes

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.

Time frame: 0, 6, 12 weeks

Data from ClinicalTrials.gov

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