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

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ClinicalTrials.gov Identifier: NCT00497939
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : July 9, 2007
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Prostatic Hyperplasia Adrenergic Alpha-Antagonists Drug: Saw palmetto and sanmiaoshan capsule

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2006
Estimated Study Completion Date : March 2008

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497939


Contacts
Contact: Annie YF Wong, Miss (852) 2632 2501 anniewong@surgery.cuhk.edu.hk

Locations
China
Prince of Wales Hospital Recruiting
Hong Kong, China
Sub-Investigator: Ping Chung Leung, Prof         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
Principal Investigator: Chi Fai Ng, Dr Department of Surgery, Division of Urology, The Chinese University of Hong Kong
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00497939     History of Changes
Other Study ID Numbers: CRE-2005.310-T
HARECCTR0500050
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Hospital Authority, Hong Kong:
Benign Prostatic Hyperplasia (BPH)
Currently on alpha blocker

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Saw palmetto extract
Urological Agents