Prostatic HyperplasiaNCT00497939
The Effectiveness of Saw Palmetto and Sanmiaoshan on Benign Prostatic Hyperplasia in Chinese Patients
A study testing Saw palmetto and sanmiaoshan capsule in people with Prostatic Hyperplasia and Adrenergic Alpha-Antagonists, run by Hospital Authority, Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Adrenergic Alpha-Antagonists
- What is being tested?
- Saw palmetto and sanmiaoshan capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Ping Chung Leung, Prof
About this study
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
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.
- Being tested
- Saw palmetto and sanmiaoshan capsule
- Keywords
- Benign Prostatic Hyperplasia (BPH), Currently on alpha blocker
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saw palmetto and sanmiaoshan capsuleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in IPSS between the study medication and placebo groups
Measured: 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
Measured: 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 (3)
Differences in IPSS and Qmax at baseline and at the end of treatment drug / placebo treatment
Measured: 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
Measured: 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
Measured: From study enrolment/ after washout period to the end of study medication / placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startJan 2006
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Chi Fai Ng, Dr, Principal investigator, Department of Surgery, Division of Urology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497939
- Sponsor's protocol ID
- CRE-2005.310-T
- Other IDs
- HARECCTR0500050
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00497939
- Acronym / sponsor ID
- CRE-2005.310-T
- Keywords
- Benign Prostatic Hyperplasia (BPH), Currently on alpha blocker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Jan 2006
- Study completion
- Mar 2008 (estimated)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 50 and 80 years old
- Clinically diagnosed to have BPH:
Key exclusion criteria (7 listed)
- Acute retention of urine
- Congestive heart failure, unstable angina, arrhythmia, myocardial infraction
- Prostatic surgery
- Prostatic malignancy
- Gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saw palmetto and sanmiaoshan capsule | Drug | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai Ng, Dr principal investigator
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saw palmetto and sanmiaoshan capsule in people with Prostatic Hyperplasia and Adrenergic Alpha-Antagonists, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie YF Wong, Miss ((852) 2632 2501, anniewong@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.