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

Primary Purpose

Prostatic Hyperplasia, Adrenergic Alpha-Antagonists

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Saw palmetto and sanmiaoshan capsule
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia (BPH), Currently on alpha blocker

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)Male

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

Sites / Locations

  • Prince of Wales HospitalRecruiting

Outcomes

Primary Outcome Measures

Differences in IPSS between the study medication and placebo groups
Differences in Qmax between the study medication and placebo groups

Secondary Outcome Measures

Differences in IPSS and Qmax at baseline and at the end of treatment drug / placebo treatment
Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and placebo group
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

Full Information

First Posted
July 6, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00497939
Brief Title
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Adrenergic Alpha-Antagonists
Keywords
Benign Prostatic Hyperplasia (BPH), Currently on alpha blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Saw palmetto and sanmiaoshan capsule
Primary Outcome Measure Information:
Title
Differences in IPSS between the study medication and placebo groups
Time Frame
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
Title
Differences in Qmax between the study medication and placebo groups
Time Frame
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 Measure Information:
Title
Differences in IPSS and Qmax at baseline and at the end of treatment drug / placebo treatment
Time Frame
From study enrolment/ after washout period to the end of study medication / placebo administration
Title
Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and placebo group
Time Frame
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
Title
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
Time Frame
From study enrolment/ after washout period to the end of study medication / placebo administration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie YF Wong, Miss
Phone
(852) 2632 2501
Email
anniewong@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Fai Ng, Dr
Organizational Affiliation
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Chung Leung, Prof

12. IPD Sharing Statement

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

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