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

July 6, 2010 updated by: Hospital Authority, Hong Kong

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Prince of Wales Hospital
        • Sub-Investigator:
          • Ping Chung Leung, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Time Frame
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
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
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
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
Time Frame: From study enrolment/ after washout period to the end of study medication / placebo administration
From study enrolment/ after washout period to the end of study medication / placebo administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Chi Fai Ng, Dr, Department of Surgery, Division of Urology, The Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion

December 7, 2022

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria

July 6, 2007

First Posted (Estimate)

July 9, 2007

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2005.310-T
  • HARECCTR0500050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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