02494nas a2200481 4500000000100000008004100001100001300042700001300055700001200068700001500080700001700095700001200112700001600124700001300140700001300153700001300166700001200179700001200191700001500203700002000218700001600238700001300254700001200267700001500279700001100294700001100305700001200316700001700328700001300345700001200358700001300370700001000383700001300393700001300406700001400419700001100433245013900444856005400583300000900637490000600646520134600652022001401998 2017 d1 aSharma S1 aKatoch K1 aSarin R1 aBalambal R1 aKumar Jain N1 aPatel N1 aMurthy KJ R1 aSingla N1 aSaha P K1 aKhanna A1 aSingh U1 aKumar S1 aSengupta A1 aBanavaliker J N1 aChauhan D S1 aSachan S1 aWasim M1 aTripathi S1 aDutt N1 aJain N1 aJoshi N1 aPenmesta SRR1 aGaddam S1 aGupta S1 aKhamar B1 aDey B1 aMitra DK1 aArora SK1 aBhaskar S1 aRani R00aEfficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial. uhttp://www.nature.com/articles/s41598-017-03514-1 a33540 v73 a

Prolonged treatment of tuberculosis (TB) often leads to poor compliance, default and relapse, converting primary TB patients into category II TB (Cat IITB) cases, many of whom may convert to multi-drug resistant TB (MDR-TB). We have evaluated the immunotherapeutic potential of Mycobacterium indicus pranii (MIP) as an adjunct to Anti-Tubercular Treatment (ATT) in Cat II pulmonary TB (PTB) patients in a prospective, randomized, double blind, placebo controlled, multicentric clinical trial. 890 sputum smear positive Cat II PTB patients were randomized to receive either six intra-dermal injections (2 + 4) of heat-killed MIP at a dose of 5 × 10(8) bacilli or placebo once in 2 weeks for 2 months. Sputum smear and culture examinations were performed at different time points. MIP was safe with no adverse effects. While sputum smear conversion did not show any statistically significant difference, significantly higher number of patients (67.1%) in the MIP group achieved sputum culture conversion at fourth week compared to the placebo (57%) group (p = 0.0002), suggesting a role of MIP in clearance of the bacilli. Since live bacteria are the major contributors for sustained incidence of TB, the potential of MIP in clearance of the bacilli has far reaching implications in controlling the spread of the disease.

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