Table 1 Details of study treatments
Group | Intervention (VISPO) | Comparator (SPO) | Placebo |
|---|---|---|---|
Treatment | Saw palmetto oil (3% β-sitosterol) | Saw palmetto oil (0.2% β-sitosterol) | Maltodextrin |
Dosage Form | Capsules | Capsules | Capsules |
Composition | Capsule weight – 500 mg Saw palmetto oil – 200 mg Maltodextrin – 300 mg | Capsule weight – 500 mg Saw palmetto oil – 200 mg Maltodextrin – 300 mg | Capsule weight – 500 mg Maltodextrin – 500 mg |
Batch No. | VH/SPO/F18716 | VH/SPO/F18717 | VH/MD/F18612 |
Route | Oral | ||
Dose | 500 mg capsule two times a day; 400 mg/day of saw palmetto oil in active treatment groups. | ||
Dosing Regimen | Twice a day after food | ||
Treatment duration | 84 days | ||