Treatment effect of Coix seed oil (KangLaiTe capsules) for patients with chronic prostatitis/chronic pelvic pain syndrome

Not Applicable

Completed

• Conditions: chronic prostatitis; chronic pelvic paiin syndrome; Renal and Urogenital - Other renal and urogenital disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12623000572662
• Lead Sponsor: Zhou Tie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-04-01
• Study Start: 2023-05-25
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 143

Inclusion Criteria

Inclusion criteria were men between 18 and 40 years of age with over 3-month history of CP/CPPS during the 6 months before study entry.

Exclusion Criteria

Exclusion criteria were those with (1) mild symptoms (NIH-CPSI score less than or equal to 14), (2) abnormal DRE or PSA values, (3) history of non-prostatitis conditions that may cause pelvic area pain or affect lower urinary tract such as urinary infection, ureteric/bladder stones, testis/epididymis/spermatic cord diseases, urethral obstruction or neurogenic disorders, (4) treatment by phytotherapeutic agents, a-receptor blockers, or antimicrobial substances 4-week prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome was the changes of national institue heathyof chronic prostatitis symptom index (NIH-CPSI) total score, this will be assessed as a composite outcome . Changes in chronic prostatitis symptoms assessed using the NIH-CPSI total score.[ commencement of intervention and at the end of the trial (12 weeks post-commencement of intervention)]

Secondary Outcome Measures

Name	Time	Method
the secondary outcomes included levels of serum immunoglobulins (IgA, IgG, IgM) [ baseline and at the end of the trial(12 weeks post-commencement of intervention)];levels of serum cytokines (TNF-a, IL-10, IL-2)[ baseline and at the end of trial(12 weeks post-commencement of intervention)];lecithin corpuscle density from expressed prostatic solution [ baseline and at the end of trial(12 weeks post-commencement of intervention)];Erectile dysfunction will be assessed using the International Index of Erectile Function-5<br>[ baseline and at the end of trial (12 weeks post-commencement of intervention)<br>];serum immune cell markers (CD3, CD4, CD8) <br><br>[ baseline and at the end of trial (12 weeks post-commencement of intervention)];NK cell viability in the blood[ baseline and at the end of trial (12 weeks post-commencement of intervention)]