CClinicalTrials.gg
Status unknownNCT00497939Updated Jul 7, 2010

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

An interventional study of Saw palmetto and sanmiaoshan capsule in Prostatic Hyperplasia and Adrenergic Alpha-Antagonists, sponsored by Hospital Authority, Hong Kong. Status unknown at 1 site in China. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-07-07.

Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostatic Hyperplasia
  • Adrenergic Alpha-Antagonists

Keywords

  • Benign Prostatic Hyperplasia (BPH)
  • Currently on alpha blocker
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's planned enrollment of 40 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Hospital Authority, Hong Kong is the lead sponsor of 73 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
40 participants (estimated)

Interventions

  • DrugSaw palmetto and sanmiaoshan capsule
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Prince of Wales Hospital
    Hong Kong, China
    • Ping Chung Leung, Prof · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00497939
Lead sponsor
Hospital Authority, Hong Kong
First posted
Jul 9, 2007
Start date
Jan 2006
Completion
Mar 2008 (estimated)
Last update
Jul 7, 2010

Study contacts

Annie YF Wong, Miss
Contact
anniewong@surgery.cuhk.edu.hk
(852) 2632 2501
Chi Fai Ng, Dr
principal investigator · Department of Surgery, Division of Urology, The Chinese University of Hong Kong
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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