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

NCT ID: NCT00497939

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Hyperplasia Adrenergic Alpha-Antagonists

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Saw palmetto and sanmiaoshan capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Chi Fai Ng, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Division of Urology, The Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Annie YF Wong, Miss

Role: CONTACT

(852) 2632 2501

Other Identifiers

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HARECCTR0500050

Identifier Type: -

Identifier Source: secondary_id

CRE-2005.310-T

Identifier Type: -

Identifier Source: org_study_id

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