Back to resultsEfficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Primary Purpose
Chronic Prostatitis, Chronic Pelvic Pain Syndrome
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Cernilton
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Prostatitis focused on measuring chronic prostatitis symptom index, male, inflammatory, CP-CPPS, Cernilton, pelvic pain, symptoms
Eligibility Criteria
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
Sites / Locations
- Justus-Liebig-University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cernilton
Placebo
Arm Description
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00919893
First Posted
February 10, 2009
Last Updated
November 4, 2020
Sponsor
University of Giessen
Collaborators
Strathmann AG&Co, Hamburg, Germany, Cernelle, Ängelholm, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00919893
Brief Title
Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Official Title
Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Giessen
Collaborators
Strathmann AG&Co, Hamburg, Germany, Cernelle, Ängelholm, Sweden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis, Chronic Pelvic Pain Syndrome
Keywords
chronic prostatitis symptom index, male, inflammatory, CP-CPPS, Cernilton, pelvic pain, symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cernilton
Arm Type
Active Comparator
Arm Description
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
Intervention Type
Drug
Intervention Name(s)
Cernilton
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
Description
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
Time Frame
0, 6, 12 weeks
Secondary Outcome Measure Information:
Title
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.
Description
Decrease of score points. Decrease of leucocytes in urine.
Time Frame
0, 6, 12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Weidner, Prof. Dr.
Organizational Affiliation
Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Justus-Liebig-University
City
Giessen
ZIP/Postal Code
D-35392
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
8499988
Citation
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.
Results Reference
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Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
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