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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00497939
• Other study ID #: CRE-2005.310-T
• Secondary ID: HARECCTR0500050
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2007
• Last updated: July 6, 2010
• Start date: January 2006
• Est. completion date: March 2008

Study information

• Verified date: July 2010
• Source: Hospital Authority, Hong Kong
• Contact: Annie YF Wong, Miss
• Phone: (852) 2632 2501
• Email: anniewong[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2008
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenergic Alpha-Antagonists
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Saw palmetto and sanmiaoshan capsule

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in IPSS between the study medication and placebo groups		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
Primary	Differences in Qmax between the study medication and placebo groups		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	Differences in IPSS and Qmax at baseline and at the end of treatment drug / placebo treatment		From study enrolment/ after washout period to the end of study medication / placebo administration
Secondary	Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and placebo group		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	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		From study enrolment/ after washout period to the end of study medication / placebo administration

External Links

•   HAREC Clinical Trial Registry