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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00497939
First received: July 6, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention
Prostatic Hyperplasia
Adrenergic Alpha-Antagonists
 Drug: Saw palmetto and sanmiaoshan capsule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • 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 ]
  • 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:
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00497939     History of Changes
Other Study ID Numbers: CRE-2005.310-T, HARECCTR0500050
Study First Received: July 6, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Permixon
Estrogen Antagonists
 Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgen Antagonists

ClinicalTrials.gov processed this record on May 23, 2013