None listed
Conditions
Brief summary
Coix seed oil (KangLaiTe capsules, KLTc) is a kind of neutral oil soft capsule extracted from coix seed, which can significantly improve the body's immunity. We aim to evaluate the efficacy of KLTc monotherapy or combined with antibiotics on patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) by the hypothesis of KLTc treament of CP by adjusting the patient's immune condition. We conducted a prospective, randomized, double-blind, positive-controlled trial with 143 men with CP/CPPS were screened. Finally 60 Patients with category IIIB CP/CPPS were enrolled in monotherapy group, randomly treated with KLTc or terzosin for 12weeks. A total of 60 patients with category IIIA CP/CPPS were enrolled in combined treatment group, treated with KLTc plus levofloxacin, or terzosin plus levofloxacin as positive control. The primary outcome was the changes of NIH-CPSI total score, and the secondary outcomes mainly focused on the immune parameters.
Interventions
The category IIIB CP/CPPS(chronic prostatitis/chronic pelvic pain syndrome) patients with normal leukocyte levels in EPS(expressed prostatic solution, expressed following a digital rectal prostate massage performed by the clinician and collected, once only) were treated with kangLaiTe capsules (KLTc), 1800 mg soft capsule three times a day for 12 weeks. The category IIIA CP/CPPS patients with abnormal leukocyte levels in EPS were treated with KLTc plus antibiotic levofloxacin (KLTc, 1800 mg so
The category IIIB CP/CPPS(chronic prostatitis/chronic pelvic pain syndrome) patients with normal leukocyte levels in EPS(expressed prostatic solution, expressed following a digital rectal prostate massage performed by the clinician and collected, once only) were treated with kangLaiTe capsules (KLTc), 1800 mg soft capsule three times a day for 12 weeks. The category IIIA CP/CPPS patients with abnormal leukocyte levels in EPS were treated with KLTc plus antibiotic levofloxacin (KLTc, 1800 mg soft capsule three times a day; levofloxacin oral tablet, 500mg once daily) 12 weeks. To monitor the adherence to the intervention, the tablet returned was recorded.
Sponsors
Zhou Tie
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Outcome results
None listed