An open-label, randomized prospective study to evaluate the efficacy and safety of Carica papaya leaf extract for thrombocytopenia associated with dengue fever in pediatric subjects

Abstract

Objective Thrombocytopenia in dengue fever (DF) is a well-known complication in both adults and pediatric subjects. Management of DF primarily includes symptomatic and intensive supportive care. There are studies available on the efficacy and safety of Carica papaya leaf extract (CPLE) in adult patients with DF. However, there are no published studies available on the efficacy and safety of CPLE in the pediatric age group. Hence, this study was conducted. Methodology A prospective, open-label, randomized controlled study was conducted in subjects aged between 1 and 12 years having thrombocytopenia associated with DF (NS-1 antigen positive) or dengue hemorrhagic fever (DHF) grades I and II. All participants were randomized into the intervention group (n =147, CPLE syrup + standard therapy) and the control group (n=147, received only standard therapy). All subjects were followed up daily for 5 days with monitoring of blood counts. Results A total of 285 subjects were finally evaluated for efficacy, and nine dropped out (seven in the control group and two in the intervention group). However, all 294 subjects were evaluated for safety. CPLE (Caripill) syrup increased the platelet count significantly compared to the control group (P<0.05). In the intervention group, the platelet count increased from day 3 onward: platelet count on day 3 (mean platelet count =89,739.31, P=0.030), day 4 (mean platelet count =120,788.96, P=0.019), and day 5 (mean platelet count =168,922.75 P=0.023). Two children complained of nausea in the intervention group. Overall, Caripill syrup was well tolerated. Conclusion CPLE syrup significantly increases the platelet count in pediatric DF patients and is well tolerated.