Efficacy and Safety of a Plant-based Nutraceutical Formulation in Dengue- Associated Thrombocytopenia: A Randomized, Open-label, Parallel-group Study

Abstract

Background: Febrile illnesses associated with thrombocytopenia, particularly Dengue, Malaria, and Typhoid fever, pose a significant public health burden in India with limited targeted therapeutic options. This study evaluated the efficacy and safety of a new Plant-based Nutraceutical Formulation's efficacy and safety.

Methods: In this randomized, open-label study (CTRI/2024/04/065599), 50 dengue patients received either plant-based nutraceuticals (Group 1) or Carica papaya leaf extract (Group 2) for 7–10 days. Clinical and lab parameters, including fever, symptoms, platelet count, clotting, bleeding, and biochemical markers, were monitored at intervals. Safety was assessed through adverse event tracking.

Results: Both groups improved in clinical and lab parameters; Group 1 showed superior and earlier outcomes. Platelet recovery was higher in Group 1 by Day 5 (65,000 vs 58,450 cells/mm³; p = 0.044). Similarly, a greater reduction in arthralgia was observed in Group 1 by Day 10 (0.05 vs 0.14), along with improved myalgia scores. Group 1 had consistently lower clotting time, better bleeding control early on, greater leukocyte recovery, and higher post-treatment sodium levels (141.5 vs 138.8). Baseline SGOT and SGPT levels were comparable between groups; however, while SGOT remained similar at the end of the study, SGPT levels increased significantly in Group 2, indicating better hepatic safety in Group 1. Both treatments were well tolerated with comparable safety profiles.

Conclusion: The Plant-based Nutraceutical Formulation showed superior efficacy in clinical and lab outcomes, confirming its role as an effective adjunct therapy for dengue-associated thrombocytopenia.