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

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919893
• Other study ID #: 4015497
• Status: Completed
• Phase: Phase 3
• Start date: December 1999
• Est. completion date: January 2004

Study information

• Verified date: June 2009
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Pelvic Pain Syndrome
• Chronic Prostatitis
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Justus-Liebig-University	Giessen

Sponsors (3)

Lead Sponsor	Collaborator
University of Giessen	Cernelle, Ängelholm, Sweden, Strathmann AG&Co, Hamburg, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0, 6, 12 weeks
Secondary	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.	0, 6, 12 weeks