Skip to main content
OpenTrials
Completed

NCT Number: NCT00919893

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Prostatitis Chronic Pelvic Pain Syndrome Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Justus-Liebig-University

Giessen, D-35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cernilton

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)

    Time frame: 0, 6, 12 weeks

    Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.

Secondary outcomes

  1. 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.

    Time frame: 0, 6, 12 weeks

    Decrease of score points. Decrease of leucocytes in urine.

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Cernelle, Ängelholm, Sweden
  • Strathmann AG&Co, Hamburg, Germany

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Jun 12, 2009
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.