Efficacy and Safety of Carica Papaya in Dengue Fever: A Randomised Clinical Trial

Introduction:

Dengue is the most important emerging viral disease of humans that, in recent decades, has become a major international public health concern. Dengue is found in tropical and subtropical regions worldwide, predominantly in urban and semi-urban areas. Dengue infection is transmitted through Aedes agypti, a Flaviviridae virus . Dengue occurs within 5-7 days after an infected mosquito bites a healthy person. There is no specific treatment for dengue; intensive supportive care is the most important aspect of management. The thrombocytopenia which usually happens in the defervescence stage of the illness is the critical phase, and if left unattended or untreated it can lead to mortality. Till now there is no approved vaccine or drug against dengue virus, therefore there is an urgent need of development of alternative solutions for dengue. Several plants species have been reported with anti-dengue activity. Researchers have indicated that the juice of the leaves of the Carica papaya plant from the family Caricaceae helps to increase the platelet levels and have demonstrated definitive beneficial effects in these patients.Carica papaya leaf extract can be used in any form for its ability on three aspects of dengue: antiviral activities, prevention of thrombocytopenia and improvement of immunity during dengue fever. Papaya leaf extract being a strong stimulant of IL-6 and SCF might help to improve thrombocytopenic conditions of the infected patients. Papaya leaves extract, rich in papain, was shown to improve thrombocyte (platelet) count in dengue patients. The qualitative phytochemical analysis reveals that except steroids and tannins all the phytochemical including glycosides, alkaloids, saponins, flavonoids, proteins are present in leaf of papaya. Papaya leaf contains anti-oxidant vitamins and minerals which may help to increase the hemoglobin,hematocrit, Red blood cells, thrombocytes and total protein contents.

Rationale:

Since there is no antiviral or vaccine to prevent dengue infections, symptomatic and supportive care must be used as the main forms of treatment. Although their effectiveness in such circumstances is debatable, prophylactic, or therapeutic platelet transfusions occasionally treat dengue-induced thrombocytopenia with or without significant hemorrhagic symptoms. Additionally, many patients find processing platelet transfusion expensive, and this platelet separation machine is unavailable in many distant places. There are several reports of using natural treatments to treat dengue thrombocytopenia. In several nations, oral administration of the extraction of Carica papaya leaves is used as a natural antipyretic treatment for dengue fever with thrombocytopenia. This extract has been shown in several experimental investigations both preclinical and clinical to have the ability to stabilize erythrocytes and stop hemolysis. Additionally, it has been demonstrated to directly influence platelets by blocking their aggregation, particularly during dengue infections. It has been demonstrated that CPLE increases platelet counts in patients with mild to moderate thrombocytopenia safely and effectively. It has not yet been determined how effective CPLE is at reducing the severity of dengue fever and the reduction of severe thrombocytopenia brought on by dengue. In this trial, the investigators want to find out the effectiveness and safety of CPLE in treating dengue patients by reducing severe progression, increasing platelet counts, and lowering the requirement for platelet transfusions.

Research question: Is CPLE effective in treating dengue patients by reducing severe disease progression and increasing platelet counts?