Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000885796
Ethics application status
Approved
Date submitted
5/08/2013
Date registered
8/08/2013
Date last updated
8/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Xuanju Compound Capsule VS Terazosin in treatment of chronic prostatitis: a Prospective Randomized Controlled Trial
Scientific title
Xuanju Compound Capsule compared with Terazosin in treatment of patients with chronic prostatitis: evaluation of symptom and NIH-CPSI
Secondary ID [1] 282965 0
Nil
Universal Trial Number (UTN)
U1111-1146-3373
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic prostatitis 289788 0
Condition category
Condition code
Renal and Urogenital 290140 290140 0 0
Other renal and urogenital disorders
Alternative and Complementary Medicine 290169 290169 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
xuanju compound capsule in treatment of chronic prostatitis; 1.26mg oral administrated 3 times daily for 12 weeks; keeping diary for taking medicine
Intervention code [1] 287672 0
Treatment: Other
Comparator / control treatment
Terazosin in treatment of chronic prostatitis; 2mg oral tablet once daily for 12 weeks; keeping diary for taking medicine
Control group
Active

Outcomes
Primary outcome [1] 290169 0
chronic prostatis symptoms assessed by NIH-CPSI score
Timepoint [1] 290169 0
3 months later after treatment
Secondary outcome [1] 304042 0
immune function asseessed by serum CD4,CD8,IgA, IgM, IgG, IL-2,IL-8, TNF-a
Timepoint [1] 304042 0
3 months later after teatment
Secondary outcome [2] 304082 0
VAS assessed by pain tools
Timepoint [2] 304082 0
3 months later after teatment

Eligibility
Key inclusion criteria
1.consistent with chronic non-bacterial prostatitis diagnosis, duration >3 months;
2.aged 18 to 50 years old;
3.Chronic Prostatitis Symptom Index (NIH-CPSI) >11 points;
4.immune dysfunction; (recommended results based on pre-select several sensitive indicators);
5.voluntarily signed informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1.except for I,II, IV type of prostatitis patients;
2.pelvic area pain, voiding dysfunction patients, benign prostatic hyperplasia, prostate cancer, testicular epididymis and spermatic cord disease, overactive bladder, neurogenic bladder, interstitial cystitis, bladder gland , sexually transmitted diseases, bladder cancer, anorectal disease, lumbar disease, central and peripheral neuropathy;
3.local pain as the main manifestation of the patients, specifically by the ureteral stones, bladder stones, inguinal hernia, pubic inflammation, varicocele, epididymitis, colorectal disease, caused by low back myofascial go far;
4.severe neurosis, mental illness;
5.past month have used drugs for treating chronic prostatitis or other relevant treatment;
6.associated with cardiovascular, cerebrovascular, liver and kidney and hematopoietic system in patients with severe primary disease, liver function ALT and / or AST> 1.5 times the upper limit of normal persons;
7.allergies, or known of the test drug ingredients or terazosin drugs have allergies;;
8.participating in the other clinical trials in a past month;
9.researchers consider it inappropriate to participate in clinical trials.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 5265 0
China
State/province [1] 5265 0
Country [2] 5285 0
Korea, Democratic People's Republic Of
State/province [2] 5285 0

Funding & Sponsors
Funding source category [1] 287739 0
Hospital
Name [1] 287739 0
shanghai changhai hospital
Country [1] 287739 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] 286465 0
Individual
Name [1] 286465 0
sun yinghao
Address [1] 286465 0
shanghai changhai hospital;changhai road 168#, shanghai , China;200433
Country [1] 286465 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289691 0
changhai hospital ethic committee
Ethics committee address [1] 289691 0
changhai road 168#, shanghai , China;200433
Ethics committee country [1] 289691 0
China
Date submitted for ethics approval [1] 289691 0
Approval date [1] 289691 0
29/07/2013
Ethics approval number [1] 289691 0

Summary
Brief summary
Immune dysfunction has been thought of to be involved in patients with chronic prostatitis. Thus we use xuanju compound capsule, a traditional chinese drug, to treat chronic prostatitis and terazosin used in control group. XUANJU capsule is a kind of chinese traditional drug and has the role in immunoregulation. If xuanju capsule indeed improve the symptom of patients with chronic prostatitis, will give strong evidence to demonstrate the important role of immune regulation in treatment of chronic prostatitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41990 0
Prof zhou tie
Address 41990 0
shanghai changhai hospital;changhai road 168#, shanghai , China;200433
Country 41990 0
China
Phone 41990 0
+86 2113918360523
Fax 41990 0
Email 41990 0
[email protected]
Contact person for public queries
Name 41991 0
Prof zhou tie
Address 41991 0
shanghai changhai hospital;changhai road 168#, shanghai , China;200433
Country 41991 0
China
Phone 41991 0
+86 2113918360523
Fax 41991 0
Email 41991 0
[email protected]
Contact person for scientific queries
Name 41992 0
Prof zhou tie
Address 41992 0
shanghai changhai hospital;changhai road 168#, shanghai , China;200433
Country 41992 0
China
Phone 41992 0
+86 2113918360523
Fax 41992 0
Email 41992 0
[email protected]

No information has been provided regarding IPD availability


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.