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A Randomized, 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
05 February 2018 (online)
Method: A double-blind, randomized placebo-controlled trial was performed in 148 patients (age: ≥3 to < 13 years children and ≥13 to ≤70 years old) at two sites. The patients were suffering from recurrent upper respiratory tract and/or lower respiratory tract infections. This study was approved by ethics committee and registered at the Clinical Trial Registry of India (CTRI/2014/06/004673). Patients satisfying all inclusion/exclusion criteria were randomly assigned to receive either placebo or Emtact 30C potency administered thrice daily for 6 months. Follow-up visits were scheduled for 6 months.
Results: Marked effect on patient's appetite was favorable in the Emtact arm (p = 0.0162). The parameters that showed significant improvement in the Emtact arm were sleep (p = 0.0084), mood/thinking ability (p = 0.028), school performance (p = 0.0034), and bothersomeness (p = 0.0499). There was a decrease in weight in the Placebo arm, while the Emtact arm had weight gain (50.7–53.96 kg). Patients suffering from continuous nose block were found to be relieved in the Emtact arm (p = 0.0402). The patients in the Emtact arm with continuous symptoms improved at a higher rate (p = 0.05) than the placebo arm. Emtact was equally effective as placebo treatment in reducing the symptoms, such as cough/expectoration and watery nasal discharge. Percentage frequency of episodes in the Emtact arm (twice a month category) was reduced (p = 0.022) from baseline to visit 5. This finding was exactly opposite in category ‘thrice in a month’, where decrease in frequency was seen in Placebo arm and increase in frequency was seen in the Emtact arm. In subgroup analysis, reduced severity of episodes was compared within two arms; more number of patients (weight < 40 kg, p = 0.0374 and age 18–49 years, p = 0.01) were converted themselves to mild categories from moderate to severe.
Keywords: Mycobacterium, tuberculosis, nosode, clinical trial