Comparative Study of Effect of Withania Somnifera As an Adjuvant to DOTS in Patients of Newly Diagnosed Sputum Smear Positive Pulmonary Tuberculosis

Background: Ashwagandha (Withania somnifera Linn.) a rejuvenative herb has long been used as an immunomodulator in Indian subcontinent. As immunity plays an important role in pathogenesis and treatment of tuberculosis (TB), so role of W. somnifera as an adjuvant has been studied on selected parameter.

Method: A randomized, double-blind placebo-control study was conducted in two groups of 60 newly diagnosed sputum smear positive pulmonary TB patients on Directly Observed Treatment - short course (DOTS) regime. W. somnifera root extract or placebo capsules were given as add-on therapy for duration of 12 weeks. Effects on sputum conversion, Hemoglobin (Hb), body weight, Erythrocyte Sedimentation Rate (ESR), RBC counts, WBC counts, CD4 and CD8 counts, Serum Glutamic-Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), serum uric acid and HRQL (Health Related Quality of Life) Index scores were studied.

Results: At the end of 8 weeks, sputum conversion was seen in 86.6% patients in study group and 76.6% in placebo group. At the end of 12 weeks a highly significant increase was seen in both CD4 and CD8 counts in study group. A raised SGOT and SGPT levels (>35IU/L) were observed in 16.6% and 33.3% patients in study group; 43.33% and 53.33% in the placebo group of patients. Elevated serum uric acid levels (>6mg/dl) were observed in 20% and 33.33% in study and placebo group respectively. Average gain in HRQL score was better in patients of study group.

Conclusion: Use of W. somnifera as an adjuvant in conjunction with anti-TB drugs used as DOTS showed a favorable effect on symptoms and immunological parameters in patients with pulmonary TB.