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

Hospital Authority, Hong Kong

Status: Unknown

Conditions: Adrenergic Alpha-Antagonists; Prostatic Hyperplasia

Treatments: Drug: Saw palmetto and sanmiaoshan capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT00497939

CRE-2005.310-T

HARECCTR0500050

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind