An open-label, 60-day trial was conducted in 75 newly diagnosed tuberculosis (TB) patients to assess the adjunctive effect of the oral immunomodulator Dzherelo with standard anti-TB chemotherapy (ATT) consisting of izoniazid, rifampicin, pyrazinamide and streptomycin (HRZS) administered as directly observed therapy (DOT). Group 1 (n = 28) with cavitary TB and group 2 (n = 17) with infiltrating pulmonary TB received 50 drops of Dzherelo twice daily in addition to HRZS. Group 3 (n = 30), which served as a control, received ATT only. Liver damage indicators, bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) decreased to normal levels in groups 1 and 2, but increased significantly in group 3. Kidney failure markers, urea and creatinine, normalized in Dzherelo recipients, but were unchanged or worsened in the ATT-only group. The changes in serum lactate dehydrogenase, catalase, malondialdehyde and diene conjugates suggested that Dzherelo downregulates TB-associated inflammation. The anti-inflammatory property of Dzherelo was further supported by a favourable haematology profile, reduced erythrocyte sedimentation rate and faster defervescence. Radiological recovery was significant in both Dzherelo groups, but not in the control group (p = 0.0085, p = 0.025 and p = 0.23, respectively). These findings correlated positively with sputum smear conversion and clinical findings (r = 0.94; p < 0.05). Mycobacterial clearance at day 30 was observed in 77%, 72% and 40% of patients in groups 1, 2 and 3, respectively. After 2 months sputum conversion rates in groups 1, 2 and 3 were 93%, 89% and 70%, respectively. Sixty-day treatment outcomes in groups 1, 2 and 3 as assessed by improvement in clinical features and respiratory function attained respective p-values of 0.008, 0.25 and 0.72, and 0.013, 0.48 and 0.0015. Dzherelo is thus useful as an immunotherapeutic adjunct in the management of TB.
