Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
NCT ID: NCT00919893
Last Updated: 2020-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
139 participants
INTERVENTIONAL
1999-12-31
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cernilton
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
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.
Placebo
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
MALE
No
Sponsors
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Strathmann AG&Co, Hamburg, Germany
UNKNOWN
Cernelle, Ängelholm, Sweden
UNKNOWN
University of Giessen
OTHER
Responsible Party
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Clinic for Urology and Pediatric Urology, JL-University, Giessen, Germany
Principal Investigators
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Wolfgang Weidner, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany
Locations
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Justus-Liebig-University
Giessen, , Germany
Countries
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References
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Rugendorff EW, Weidner W, Ebeling L, Buck AC. Results of treatment with pollen extract (Cernilton N) in chronic prostatitis and prostatodynia. Br J Urol. 1993 Apr;71(4):433-8. doi: 10.1111/j.1464-410x.1993.tb15988.x.
Other Identifiers
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4015497
Identifier Type: -
Identifier Source: org_study_id