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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

July 6, 2007
July 6, 2010
January 2006
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  • 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 ]
Same as current
Complete list of historical versions of study NCT00497939 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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The Effectiveness of Saw Palmetto and Sanmiaoshan on Benign Prostatic Hyperplasia in Chinese Patients
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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Prostatic Hyperplasia
  • Adrenergic Alpha-Antagonists
Drug: Saw palmetto and sanmiaoshan capsule
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2008
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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
Male
50 Years to 80 Years
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Contact: Annie YF Wong, Miss (852) 2632 2501 anniewong@surgery.cuhk.edu.hk
China
 
NCT00497939
CRE-2005.310-T, HARECCTR0500050
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Hospital Authority, Hong Kong
Not Provided
Principal Investigator: Chi Fai Ng, Dr Department of Surgery, Division of Urology, The Chinese University of Hong Kong
Hospital Authority, Hong Kong
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP