Adrenergic Alpha-Antagonists, Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia (BPH), Currently on alpha blocker
Brief summary
The purpose of this study is to assess the effect of saw palmetto and sanmiaoshan, on top of alpha blocker, on urinary flow rate and BPH symptoms in patients with BPH.
Interventions
DRUGSaw palmetto and sanmiaoshan capsule
Sponsors
Hospital Authority, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Inclusion criteria
* Age between 50 and 80 years old * Clinically diagnosed to have BPH: * Suffered from lower urinary tract symptoms with IPSS\>=8 * Detectable prostatic enlargement determined by DRE * Urinary flow between 5 and 15ml/second in a total void volume \>=150mL * Serum PSA level less than 4ng/ml or in between 4-10 ng/ml with percent free PSA \>25% or\>=4 with cancer excluded by biopsy
Exclusion criteria
* Acute retention of urine * Congestive heart failure, unstable angina, arrhythmia, myocardial infraction * Prostatic surgery * Prostatic malignancy * Gastrointestinal disease * Renal impairment with serum creatinine \>140 umol/l * Hepatic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in IPSS between the study medication and placebo groups | At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment |
| Differences in Qmax between the study medication and placebo groups | At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment |
Secondary
| Measure | Time frame |
|---|---|
| Differences in IPSS and Qmax at baseline and at the end of treatment drug / placebo treatment | From study enrolment/ after washout period to the end of study medication / placebo administration |
| Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and placebo group | At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment |
| Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and baseline, and placebo group and baseline | From study enrolment/ after washout period to the end of study medication / placebo administration |
Countries
China
Contacts
Primary ContactAnnie YF Wong, Miss
Outcome results
None listed