Efficacy of Antituberculous Therapy in Management of Sarcoidosis

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

newly diagnosed sarcoidosis defined by presence of all of the following criteria:

1. Presence with clinical features of pulmonary (dyspnea, dry cough, chest pain, fever, fatigue or crackles) or extra pulmonary organ (lymph nodes, liver, spleen, skin, eyes, heart, etc.) involvement and consistent radiological involvement and

2. Compact non-caseating granulomas on trans-bronchial biopsy which are tissue AFB smear-negative

Exclusion Criteria:

Patients who have received glucocorticoid treatment before initial evaluation by us, or with presence of concomitant other cardio pulmonary disease will be excluded.