NCT00497939.

Study name	The effectiveness of saw palmetto and sanmiaoshan on benign prostatic hyperplasia in Chinese patients
Methods	Cross‐over randomized controlled trial
Participants	Inclusion criteria: Age between 50 and 80 years old Clinically diagnosed as having BPH Suffered from lower urinary tract symptoms with IPSS >= 8 Detectable prostatic enlargement determined by DRE Urinary flow between 5 and 15 mL/s in a total void volume >= 150 mL Serum PSA level < 4 ng/mL or between 4 and 10 ng/mL with per cent 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
Interventions	Saw palmetto and sanmiaoshan capsule plus alpha‐blockers
Outcomes	Primary outcomes Differences in IPSS between the study medication and placebo groups (baseline, 6 months, end of washout period, and 6 months after cross‐over) Differences in Qmax between the study medication and placebo groups (baseline, 6 months, end of washout period, and 6 months after cross‐over) Secondary outcomes Differences in IPSS and Qmax at baseline and at the end of treatment drug/placebo treatment (baseline and after washout and end of the study) Mean urinary flow rate, postvoid residual volume, prostate volume, PSA and GHQ score between study medication group and placebo group (baseline, 6 months, end of washout period, and 6 months after cross‐over) Mean urinary flow rate, postvoid residual volume, prostate volume, PSA and GHQ score between study medication group and baseline, and placebo group and baseline (baseline, 6 months, end of washout period, and 6 months after cross‐over and end of the study)
Starting date	January 2006
Contact information	Annie YF Wong Tel: (852) 2632 2501 anniewong@surgery.cuhk.edu.hk (contacted on 30 December 2022)
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