Abstract:
Background: Benign Prostatic Hyperplasia (BPH) is the most common condition in ageing
men, associated with Lower Urinary Tract Symptoms (LUTS). Being a cause of significant
morbidity in ageing man, various observational studies were conducted by the Council with
a positive outcome. This protocol has been prepared to further ascertain the usefulness of
constitutional/organ remedies in LUTS for men with BPH in a randomized control setting.
Objectives: The primary objective is to compare the changes in IPSS (International
Prostate Symptom Score) within the three groups enrolled for the study (Constitutional
remedy/Constitutional + Organ remedy/Placebo). The secondary objectives are
to compare the changes in Prostate volume, Post Void Residual Urine (PVRU),
Uroflowmetry and in WHOQOL–BREF.
Material and Methods: It is an open randomized placebo controlled clinical trial. The
prescription of the constitutional remedies/organ remedies/placebo is done as per the
randomization chart and the selection of these remedies is done as per the guidelines
laid in the Organon of Medicine. The outcome measures including IPSS (monthly),
prostate volume, post void residual urine, uroflowmetry and the WHOQOL–BREF are
assessed at baseline, three and six months interval.
Discussion: Results from this trial will help in constructing treatment strategy for BPH
patients with lower urinary tract symptoms in improving their quality of life.
Trial Registration: Clinical Trial Registry ‑ India: CTRI/2012/05/002649.
