A Randomised, Double-Blind Placebo-Controlled, Multi-Centric Clinical Trial of Ultra-Diluted Mycobacterium tuberculosis Nosode (Emtact 30c) in the Management of Recurrent Upper and Lower Respiratory Tract Affections

Abstract

Introduction Due to the rising incidence of respiratory infections, numerous interventions are being tried as preventive/therapeutic alternatives. The Emtact 30c is a polyvalent nosode prepared from various strains of Mycobacterium tuberculosis organisms. The objective of this clinical trial was to investigate the efficacy of Emtact 30c by measuring the reduction in frequency, severity of episodes and relief in recurrent upper/lower respiratory tract (URT/LRT) affections. Method A double-blind, randomised placebo-controlled trial was carried out on 148 patients in a 1:1 allocation ratio. Patients satisfying inclusion/ exclusion criteria were randomised to receive either placebo or Emtact 30c administered thrice daily for 6 months. Result There was a significant reduction in symptoms like nasal blockage, sneezing, watery nasal discharge, disturbed sleep and bothersomeness in the Emtact-treated arm. A significant decrease in symptoms (nose block) was observed in Emtact-arm (p < 0.001). The parameters that showed significant improvement in Emtact-arm were sleep (p = 0.0084), mood/thinking ability (p = 0.028) and bothersomeness (p = 0.0499). The marked effect on appetite was favourable in Emtact-arm (p = 0.0078). There was a decrease in weight in the placebo arm, while the Emtact- arm had weight gain. An improvement in haemoglobin and lymphocytes was an important outcome of this study. The trial has shown that Emtact has reduced the symptoms and severity of URT and LRT affections. Conclusion Emtact may be used as a safe and efficacious alternative to treat URT and LRT affections. More studies evaluating mechanisms at biochemical and molecular levels would help.