Effectiveness of Tuberculinum 200C in preventing latent and active tuberculosis in household contacts of index case - a prospective, household-cluster randomized, double blind, placebo controlled trial

This is a prospective, household-cluster randomized, double blind placebo controlled trial to assess the effectiveness of Tuberculinum 200C in preventing the incidence of latent and active Tuberculosis among household contacts of the index case. In the study, approximately 1,000 apparently healthy participants, who are household contacts of Tuberculosis patients residing in Guwahati, Assam shall be enrolled in 02 groups. Group 1 (medicine group) shall be administered Tuberculinum 200C, one dose a month for 03 months; whereas, Group 2 (control group) shall be given placebo, one dose a month for 03 months. The participants shall be followed up for a period of 12 months (including 03 months of intervention).  The primary outcome measure will be the incidence of latent or active tuberculosis infection among household contacts. The secondary outcome measure will be adverse effects due to Tuberculinum 200C and time to appearance of clinical symptoms of Tuberculosis in household contacts (HHC) of pulmonary TB (PTB) patients.