drugset / Trial / NCT01245036

Efficacy of Antituberculous Therapy in Management of Sarcoidosis

NCT01245036

RandomizedParallel-groupOpen-labelTreatment

Summary

From the time sarcoidosis has been described, there has always been a belief that the disease is in some way related to tuberculosis. If indeed tuberculosis is a causal factor in sarcoidosis, then the hypothesis can be further reinforced, if anti-tubercular therapy (ATT) is useful in treatment of sarcoidosis. Very few trials have been conducted in the past but the results of these trials have been discouraging. These trials were generally small studies and limited by time bias and used older regimens based on isoniazid, amino-salicylic acid and streptomycin. In our experience nearly one third of patients who are finally diagnosed to have sarcoidosis, have received ATT for variable length of time, but its impact of final outcome of sarcoidosis has not been studied. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of Rifampicin and Isoniazid along with prednisolone compared to prednisolone alone in treatment of Sarcoidosis.

Timeline

Start
2009-01
Primary completion
2012-12
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator INH Unknown 300 mg
Comparator Rifampin Small molecule 450 mg
Comparator Rifampin Small molecule 600 mg
Comparator Prednisolone Other / unclassified 0.25 mg/kg