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.

Keywords

Emtact - homoeopathic - Mycobacterium tuberculosis nosode - respiratory tract affections - ultra dilute

Authors' Contributions

Feroz Shaik and Arjun Singh helped in clinical trial work and patient recruitment. Gitanjali Talele helped in clinical trial design, management and manuscript writing. Rajesh Shah, principal investigator and inventor of the drug, contributed to conceptualisation, clinical trial design and supervision and manuscript writing.

Note

Oral abstract published in Homeopathy 2018; 107(S 01): 55−78. DOI: 10.1055/s-0038-163330.

Publication History

Article published online:
25 May 2023

• References

• 1 Selwyn BJ. ; Coordinated Data Group of BOSTID Researchers. The epidemiology of acute respiratory tract infection in young children: comparison of findings from several developing countries. Rev Infect Dis 1990; 12 (Suppl. 08) S870-S888
• 2 Nichol KL, D'Heilly S, Ehlinger E. Colds and influenza-like illnesses in university students: impact on health, academic and work performance, and health care use. Clin Infect Dis 2005; 40 (09) 1263-1270
• 3 Jesenak M, Ciljakova M, Rennerova Z, Babusikova E, Banovcin P. Recurrent respiratory infections in children - definition, diagnostic approach, treatment and prevention. InTech; 2011. DOI: 10.5772/19422
• 4 Esposito S, Musio A. Immunostimulants and prevention of recurrent respiratory tract infections. J Biol Regul Homeost Agents 2013; 27 (03) 627-636
• 5 Arora S, Arora B. Use of nosodes in homeopathic clinical practice: a survey. Revista De Homeopatia 2015; 78: 8-13
• 6 Shah R. HIV nosode: the homeopathic pathogenetic trial. Forsch Komplement Med 2015; 22 (03) 156-162
• 7 Shah R. Clinical trial for evaluation of a human immunodeficiency virus nosode in the treatment for human immunodeficiency virus-infected individuals. Ind J Res Homoeopath 2015; 9 (01) 25
• 8 Siqueira CM, Homsani F, da Veiga VF. et al. Homeopathic medicines for prevention of influenza and acute respiratory tract infections in children: blind, randomized, placebo-controlled clinical trial. Homeopathy 2016; 105 (01) 71-77
• 9 Bracho G, Varela E, Fernández R. et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy 2010; 99 (03) 156-166
• 10 Shah R. Scientific method of preparing homoeopathic nosodes. Ind J Res Homoeopathy 2014; 9: 25-33
• 11 William B. Pocket Manual of Homeopathic Materia Medica with Indian Medicine and Repertory, by Boericke 9th edition revised and enlarged. New Delhi: Indian Books and Periodicals Publishers; 2008: 655-659
• 12 Joshi S, Mukerjee S, Vaidya S, Talele G, Chowdhary A, Shah R. Preparation, standardization and in vitro safety testing of Mycobacterium nosodes (Emtact- polyvalent nosode). Homeopathy 2016; 105 (03) 225-232
• 13 Shah R. A clinical evaluation of a hepatitis C Nosode in the treatment of hepatitis C. J Altern Complement Med 2016; 22 (03) 197-203
• 14 Shah R. Clinical trial for evaluation of a human immunodeficiency virus nosode in the treatment for human immunodeficiency virus-infected individuals. Indian J Res Homoeopathy 2015; 9: 25-33
• 15 Smith AP. Behavioral effects of upper respiratory tract illnesses: a consideration of possible underlying cognitive mechanisms. Behav Sci (Basel) 2012; 2 (01) 38-49
• 16 Homoeopathic Pharmacopeia of India. 1st ed, 4th Vol.. New Delhi: Ministry of Health Government of India; 1983: 136-137
• 17 Tye J. The Invisible Factor—An Inquiry into the Relationship between Influenza and Accidents. London, UK: British Safety Council; 1960
• 18 Grant J. Postinfluenzal judgement deflection among scientific personnel. Asian J Med 1972; 8: 535-539
• 19 De Sutter AIM, Saraswat A, van Driel ML. Antihistamines for the common cold. Cochrane Database Syst Rev 2015; 2015 (11) CD009345
• 20 Lui CT. Prescription practice of antihistamines for acute upper respiratory tract infections in pediatric patients in a local emergency department in Hong Kong. World J Emerg Med 2017; 8 (01) 47-54
• 21 Bhuyan GS, Hossain MA, Sarker SK. et al. Bacterial and viral pathogen spectra of acute respiratory infections in under-5 children in hospital settings in Dhaka city. PLoS One 2017; 12 (03) e0174488
• 22 Huaman MA, Fiske CT, Jones TF. et al. Tuberculosis and the risk of infection with other intracellular bacteria: a population-based study. Epidemiol Infect 2015; 143 (05) 951-959
• 23 Schurr E. Is susceptibility to tuberculosis acquired or inherited?. J Intern Med 2007; 261 (02) 106-111
• 24 Fernando SL, Britton WJ. Genetic susceptibility to mycobacterial disease in humans. Immunol Cell Biol 2006; 84 (02) 125-137