Sudeep 2020.

Study characteristics
Methods	Study design: double‐blind, parallel‐group randomized trial Study dates: not available Setting: outpatient, single center, national Country: India
Participants	Inclusion criteria: IPSS score > 7 Aging Male Symptoms (AMS) score ≥ 27 and responding positively to question 1 or 7 or any other 3 questions of the Androgen Deficiency in the Aging Male (ADAM) questionnaire Exclusion criteria: Neurogenic bladder dysfunction Prostatic cancer Prostatitis Hematuria Diabetes Any other chronic illness Sample size: 99 randomized participants Age (years): Group 1 mean (SD): 57.76 (7.25) Group 2 mean (SD): 55.18 (8.56) Group 3 mean (SD): 57.48 (7.04) IPSS score (baseline): Group 1 mean (SD): 20.00 (4.41) Group 2 mean (SD): 20.00 (3.74) Group 3 mean (SD): 19.45 (3.82) Prostate size: not available
Interventions	Group 1 (n = 33): saw palmetto extract VISPO (containing 3% beta‐sitosterol ‐ 200 mg of Serenoa repens extract) 500 mg doses twice daily for 12 weeks Group 2 (n = 33): placebo (maltodextrin) for 12 weeks Group 3 (n = 33): saw palmetto oil SPO (0.2% beta‐sitosterol ‐ 200 mg of Serenoa repens extract) for 12 weeks Co‐interventions: none
Outcomes	Urinary symptoms How measured: IPSS Time points measured: 0, 6, and 12 weeks Time points reported: 0, 6, and 12 weeks Subgroups: none Adverse events How measured: not described Time points measured: possibly at 12 weeks follow‐up Time points reported: possibly at 12 weeks follow‐up Subgroups: none Other outcomes measured in the trial: urinary retention, Qmax, PSA, 5‐alpha‐reductase, testosterone, AMS, and ADAM
Notes	Funding sources: Vidya Herbs Private Ltd Declarations of interest: none