Clinical trial NCT00497939: The Effectiveness of Saw Palmetto and Sanmiaoshan on Benign Prostatic Hyperplasia in Chinese Patients
Official title: The Effectiveness of Saw Palmetto and Sanmiaoshan on International Prostate Symptom Score and Peak Urinary Flow Rate of Chinese Patients With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Hyperplasia
Adrenergic Alpha-Antagonists
Keywords: Benign Prostatic Hyperplasia (BPH)
Currently on alpha blocker
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-07-09
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Differences in IPSS between the study medication and placebo groups
timeFrame: 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
measure: Differences in Qmax between the study medication and placebo groups
timeFrame: 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 outcomes:
measure: Differences in IPSS and Qmax at baseline and at the end of treatment drug / placebo treatment
timeFrame: From study enrolment/ after washout period to the end of study medication / placebo administration
measure: Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and placebo group
timeFrame: 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
measure: 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
timeFrame: From study enrolment/ after washout period to the end of study medication / placebo administration
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Department of Surgery, Division of Urology, The Chinese University of Hong Kong
name: Chi Fai Ng, Dr
role: PRINCIPAL_INVESTIGATOR
References: