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

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of Saw Palmetto and Sanmiaoshan on International Prostate Symptom Score and Peak Urinary Flow Rate of Chinese Patients With Benign Prostatic Hyperplasia

Conditions
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Prostatic Hyperplasia, Adrenergic Alpha-Antagonists

Intervention / Treatment
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* Drug: Saw palmetto and sanmiaoshan capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Saw palmetto and sanmiaoshan capsule|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia (BPH), Currently on alpha blocker