The Effectiveness of Saw Palmetto and Sanmiaoshan on Benign Prostatic Hyperplasia in Chinese Patients
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 6, 2007
CompletedFirst Posted
Study publicly available on registry
July 9, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJuly 7, 2010
July 1, 2010
July 6, 2007
July 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chi Fai Ng, Dr
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 6, 2007
First Posted
July 9, 2007
Study Start
January 1, 2006
Study Completion
March 1, 2008
Last Updated
July 7, 2010
Record last verified: 2010-07