A randomized controlled study to assess role of serratiopeptidase as companion drug to standard anti tuberculosis drug regimen in achieving good clinical outcome among patients of Extra Pulmonary Tuberculosis.

Tuberculosis (TB) continues to be a major public health challenge globally, especially in low and middle income countries like India. While pulmonary TB is more commonly recognized, extrapulmonary tuberculosis (EPTB) comprises a significant portion of the disease burden, accounting for approximately 15 to 20 percent of cases in immunocompetent individuals and over 50 percent in immunocompromised populations such as those living with HIV or AIDS.EPTB may affect virtually any organ including lymph nodes, pleural skeletal systems, genitourinary tract, abdomen, central nervous system (CNS), pericardium, and reproductive organs. The complications associated with EPTB vary depending on the site of involvement and may include abscess formation, pleural thickening, vertebral deformities, infertility, neurological deficits, and even life-threatening conditions like cardiac tamponade and hydrocephalus. These complications often arise due to delayed diagnosis, prolonged inflammation, and inadequate tissue healing. This randomized controlled study is designed to evaluate the efficacy of serratiopeptidase drug, a proteolytic enzyme with anti-inflammatory, fibrinolytic, and analgesic properties, as an adjunct to standard anti-tubercular therapy (ATT) in preventing complications and achieving better clinical outcomes in EPTB. Serratiopeptidase has been used in various inflammatory and post-operative conditions, and preliminary retrospective data suggest its potential in enhancing tissue healing and reducing complications in TB-related hydro-pneumothorax. Given this background, this study aims to systematically evaluate its benefits in multiple forms of EPTB. The study will be conducted in 2025 at the Department of Pulmonary Medicine, SRN Hospital, MLN Medical College, Prayagraj. Eligible participants will include adult patients (greater than 18 years) newly diagnosed with EPTB, confirmed by experts in the respective organ systems based on relevant clinical and diagnostic criteria. Patients will be randomized into two groups: the intervention group will receive serratiopeptidase 15 mg twice daily for 2 months (during intensive phase of ATT), alongside standard full course ATT regimen under National TB Elimination Program (NTEP), while the control group will receive standard full course ATT only, under NTEP. Exclusion criteria include pulmonary TB, co-morbid conditions such as HIV, diabetes, liver disease, pregnancy, steroid or anticoagulant therapy, prior TB treatment, or known allergy to serratiopeptidase. Participants will undergo baseline investigations, including CBC, LFT, KFT, PT or INR, HIV status, HbA1C, and other organ-specific diagnostics. Monthly follow-up visits will monitor clinical improvement and identify any emerging complications or adverse effects. Relevant lab investigations will be repeated during each follow-up.The primary objective is to determine whether the addition of serratiopeptidase for 2 months to standard ATT regimen, can achieve good clinical outcome and reduce the incidence and severity of complications associated with EPTB.The data collected will be analyzed using appropriate statistical tools to assess efficacy and safety outcomes. This study is expected to contribute significantly to the evidence base supporting adjunctive therapies in TB management, particularly in resource-constrained settings, where reducing surgical interventions and improving recovery can have substantial public health benefits. All patient data will be handled with strict confidentiality, and institutional ethics approval will be obtained before commencing the study.