The Effectiveness of Saw Palmetto and Sanmiaoshan on Benign Prostatic Hyperplasia in Chinese Patients

Not Applicable

• Conditions: Prostatic Hyperplasia; Adrenergic Alpha-Antagonists

• Registration Number: NCT00497939
• Lead Sponsor: Hospital Authority, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-07-06
• Study First Submitted QC: 2007-07-06
• Study First Posted: 2007-07-09
• Study Completion: 2008-03
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China