A randomized, double-blind, placebo-controlled, proof of concept study to assess the safety and efficacy of Carica papaya and Tinospora cordifolia leaf extract (Thrombobliss) in subjects undergoing chemotherapy treatment and subjects with systemic microbial infection and subsequent reduction in platelet count

Abstract

Background: Thrombocytopenia is defined as persistent decrease in the number of blood platelets. Thrombocytopenia usually serves as symptom for identifying hematologic malignancies, infectious diseases, auto-immune disorders and as common side effect of about 200 different disease types. There was neither a specific treatment available for thrombocytopenia, nor to increase the platelet count leading to mortality. Current methods are less effective and have their limitations. This study was conducted to prove that Carica papaya and Tinospora cordifolia leaf extract can increase the platelet count in study subjects with dengue, other microbial infections. Methods: Totally 250 patients were randomized, subjects within inclusion criteria and exclusion criteria were randomly assigned, in a 1:1 ratio, to receive orally thrombobliss in a dose of 5 ml syrup twice daily or placebo for five consecutive days. Platelet count was monitored every day.Results: The result showed that there is increase in the platelet count from day 2 in median platelet data and more evident after 72 hours seen in both mean and median platelet count. Even in the cancer patients undergoing chemotherapy, there has been significant increase in platelet count. The statistical analysis of the data showed that there is a significant increase in platelet count and is statistical significant p<0.05. Conclusions: This study showed that novel combination of Carica papaya and Tinospora cordifolia leaf extract effectively increases platelet count and can be used to treat thrombocytopenia. It is also evident that this combination is safe and effective in treating thrombocytopenia patients due to dengue and other microbial infection.