Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000572662
Ethics application status
Approved
Date submitted
11/03/2023
Date registered
25/05/2023
Date last updated
10/12/2023
Date data sharing statement initially provided
25/05/2023
Date results information initially provided
25/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment effect of Coix seed oil (KangLaiTe capsules) for patients with chronic prostatitis/chronic pelvic pain syndrome
Scientific title
Efficacy of Coix seed oil (KangLaiTe capsules) for patients with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind, positive-controlled trial
Secondary ID [1] 309131 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic prostatitis 329224 0
chronic pelvic paiin syndrome 330081 0
Condition category
Condition code
Inflammatory and Immune System 326183 326183 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 326977 326977 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325578 0
Treatment: Drugs
Comparator / control treatment
As the control, the category IIIB patients with normal leukocyte levels in EPS were treated with terazosin (oral tablet 2 mg once daily) for 12 weeks; While the category IIIA CP/CPPS patients were treated with terazosin plus levofloxacin (terazosin oral table 2mg once daily; levofloxacin oral tablet 500mg once daily) for 12 weeks. To monitor the adherence to the intervention, the tablet returned was recorded.
Control group
Active

Outcomes
Primary outcome [1] 334062 0
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.
Timepoint [1] 334062 0
commencement of intervention and at the end of the trial (12 weeks post-commencement of intervention)
Secondary outcome [1] 419234 0
the secondary outcomes included levels of serum immunoglobulins (IgA, IgG, IgM)
Timepoint [1] 419234 0
baseline and at the end of the trial(12 weeks post-commencement of intervention)
Secondary outcome [2] 421051 0
levels of serum cytokines (TNF-a, IL-10, IL-2)
Timepoint [2] 421051 0
baseline and at the end of trial(12 weeks post-commencement of intervention)
Secondary outcome [3] 421052 0
lecithin corpuscle density from expressed prostatic solution
Timepoint [3] 421052 0
baseline and at the end of trial(12 weeks post-commencement of intervention)
Secondary outcome [4] 421053 0
Erectile dysfunction will be assessed using the International Index of Erectile Function-5
Timepoint [4] 421053 0
baseline and at the end of trial (12 weeks post-commencement of intervention)
Secondary outcome [5] 422162 0
serum immune cell markers (CD3, CD4, CD8)

Timepoint [5] 422162 0
baseline and at the end of trial (12 weeks post-commencement of intervention)
Secondary outcome [6] 422163 0
NK cell viability in the blood
Timepoint [6] 422163 0
baseline and at the end of trial (12 weeks post-commencement of intervention)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive data were presented as numbers (%) while continuous data were presented as mean ± standard deviation. Statistical analysis included two tailed paired/unpaired test to compare domains scores within each group or between both groups. Chi-square test was carried out to compare categorical variables in both groups. Pearson studies applied to define the correlation between differential IIEF-5 score and differential CPSI domains (both presented as percentage). A p < 0.05 was considered to be statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
Actual
10/12/2018
Date of last data collection
Anticipated
Actual
1/04/2019
Sample size
Target
120
Accrual to date
Final
143
Recruitment outside Australia
Country [1] 25310 0
China
State/province [1] 25310 0
shanghai

Funding & Sponsors
Funding source category [1] 313334 0
Self funded/Unfunded
Name [1] 313334 0
Zhou Tie
Country [1] 313334 0
China
Primary sponsor type
Individual
Name
Zhou Tie
Address
shanghai changhai hospital, changhai road 168#,Shanghai, China, 200433
Country
China
Secondary sponsor category [1] 315076 0
None
Name [1] 315076 0
none
Address [1] 315076 0
none
Country [1] 315076 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312556 0
Shanghai Changhai Hospital Ethics Committee
Ethics committee address [1] 312556 0
changhai road 168#,Shanghai,China, 200433
Ethics committee country [1] 312556 0
China
Date submitted for ethics approval [1] 312556 0
Approval date [1] 312556 0
25/03/2018
Ethics approval number [1] 312556 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
KLTc is used in tumor patients for immune improvement. We firstly used KLTc in chronic prostatis just based on its function as immune adjustment. So when we apply for ethics approval, the ethics committee let us try some patients before application. So we finally get the approval on 25/3/2018.

Contacts
Principal investigator
Name 125074 0
Prof Zhou Tie
Address 125074 0
shanghai changhai hospital, changhai road 168#,Shanghai. China, 200433
Country 125074 0
China
Phone 125074 0
+8602113918360523
Fax 125074 0
Email 125074 0
wenzhoutie@163.com
Contact person for public queries
Name 125075 0
Prof Zhou Tie
Address 125075 0
shanghai changhai hospital, changhai road 168#, Shanghai , China, 200433
Country 125075 0
China
Phone 125075 0
+8602113918360523
Fax 125075 0
Email 125075 0
wenzhoutie@163.com
Contact person for scientific queries
Name 125076 0
Prof Zhou Tie
Address 125076 0
shanghai changhai hospital, changhai road 168#,Shanghai, China, 200433
Country 125076 0
China
Phone 125076 0
+8602113918360523
Fax 125076 0
Email 125076 0
wenzhoutie@163.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
these data refers to the private information of patients and should get the agreement of the patients before releasement.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.