A post marketing randomized placebo controlled study to evaluate the efficacy of study product UPLAT® (Carica papaya leaf extract + Tinospora cordifolia extract) in the cancer patients with thrombocytopenia induced by chemotherapy

ABSTRACT

Background:Thrombocytopenia refers to abnormal decrease in platelet count in an individual. The condition may rise at different grades of severity in cancer patients under chemotherapy. In most of the cases, thrombocytopenic condition of cancer patient becomes a major therapy limiting factor. Generally, the treatment of thrombocytopenia lies in dose reduction and/or dose delay but this may adversely affect the treatment plan of cancer. Therefore, managing chemotherapy induced thrombocytopenia is still a challenge. This study was conducted to examine the platelet count improving effect of marketed product UPLAT® (Carica papayaleaf extract + Tinospora cordifoliaextract) in cancer patients with chemotherapy induced thrombocytopenia (CIT).Methods:Fourty (40) subjects were recruited as „case? and twenty (20) as „control?. „Cases? were cancer patients with chemotherapy induced thrombocytopenia. UPLAT® containing following active ingredients;Carica papayaleaf extract 350mg (standardized to 2% flavonoids)and Tinospora cardifoliaextract 150mg (standardized to 3% bitters) was given twice daily (2units each) for 10 consecutive days. Platelet count was observed at baseline and day 15 (end of the study). Then pre and post-treatment platelet counts were compared individually in both arms by statistical tests. Response was evaluated in fourty (40) „cases? and twenty „control?y.Results:Mean change for platelet count in case group (93990.00±63896.73) was much higher than control group(27600.00±29758.42).No adverse events with the treatment were observed. Conclusions: This study proves the effectiveness of platelet booster UPLAT® (combination of Carica papayaleaf extract and Tinospora cordifolia) as it significantly increased thrombocytes/platelet count in post-chemotherapy cancer patients.