An exploratory double-blind placebo controlled randomized parallel group multi-centric study to evaluate the safety tolerability and efficacy of LinumLife EXTRA (Dose I & II) compared to placebo in subjects with Benign Prostatic Hyperplasia

Benign ProstaticHyperplasia (BPH) is associated withbothersome lower urinary tract symptoms (LUTS) that affect quality of life byinterfering with normal daily activities and sleep patterns. The prevalence ofbothersome symptoms also increases with age. Treatment of BPH iscurrently undergoing intense scrutiny due to the cost and morbidity{complications and disability due to the procedure associated with the “goldstandard†treatment, Transurethral Resection of the Prostate (TURP)} but this along with bladder neck incision arecostly and have adverse effects including bleeding, infection and sexualdysfunction such as retrograde ejaculation, and may not be required in less severe cases. Hence it isthe need of time to look out for oral medications for BPH with minimal sideeffects. There is a need to develop other treatments, especially for subjectsunfit for surgery or with less severe symptoms. Themodern drugs do provide symptomatic relief to the patient, which is the mostimportant target to be achieved in these subjects. In the present study, theaim is to assess these formulations as a supportive therapy for symptoms of BPHand at the same time to determine their efficacy. In this study we are tryingto evaluate these herbal formulations and monitor whether the InvestigationalProduct (IP) LinumLife Extra (two active doses) can maintain and furtherprovide greater symptomatic relief to subjects with BPH