Homoeopathic therapy for lower urinary tract symptoms in men with Benign Prostastic Hyperplasia: An open randomized multicentric placebo controlled clinical trial

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.