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

NCT00919893 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2020-11-20

Study results available
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Summary

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.

Conditions

  • Chronic Prostatitis
  • Chronic Pelvic Pain Syndrome

Interventions

DRUG

Cernilton

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Strathmann AG&Co, Hamburg, Germany

    collaborator UNKNOWN

  • Cernelle, Ängelholm, Sweden

    collaborator UNKNOWN

  • University of Giessen

    lead OTHER

Principal Investigators

  • Wolfgang Weidner, Prof. Dr. · Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-12-31
Primary Completion
2004-01-31
Completion
2004-01-31

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00919893 on ClinicalTrials.gov