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

Authors

  • Rajeev Tiwari Sanat Products Limited, Sagar Plaza, Distt. Centre, Laxmi Nagar, Vikas Marg, Delhi, India
  • Deepak Kumar Mandal North East Cancer Centre Hospital and Research Institute, Jarobat, Guwahati, Assam, India
  • Jigar Patel Aman Hospital and Research Center, Shashwat, Opp E.S.I Hospital, Gotri Road, Vadodara, Gujarat, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20183376

Keywords:

Carica papaya, Tinospora cordifolia, Chemotherapy, Thrombocytopenia

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 papaya leaf extract + Tinospora cordifolia extract) 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 papaya leaf extract: 350 mg (standardized to 2% flavonoids) and Tinospora cardifolia extract: 150 mg (standardized to 3% bitters) was given twice daily (2 units 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 papaya leaf extract and Tinospora cordifolia) as it significantly increased thrombocytes/platelet count in post-chemotherapy cancer patients.

 

References

Liebman HA. Thrombocytopenia in cancer patients. Thromb Res. 2014;133:63–9.

Kuter DJ. General aspects of thrombocytopenia, platelet transfusions, and thrombopoietic growth factors. Consultative Hemostasis and Thrombosis: Third Edition. 2013: 103-116.

NORD (National Organization of Rare Disorders). Available at: https://rarediseases.org/rare-diseases/immune-thrombocytopenia/. Accessed on 3 March 2018.

Refaai MA, Phipps RP, Spinelli SL, Blumberg N. Platelet transfusions: impact on hemostasis, thrombosis, inflammation and clinical outcomes. Thrombosis research. 2011;127(4):287-91.

Kuter DJ. Milestones in understanding platelet production:a historical overview. Br J Haematol. 2014;165:248-58.

Kuter DJ, Begley CG. Recombinant human thrombopoietin:basic biology and evaluation of clinical studies. Blood. 2002;100:3457-69.

Kuter DJ. The biology of thrombopoietin and thrombopoietin receptor agonists. Int J Hematol. 2013;98:10-23.

Xiao Y, Liu J, Huang XE, Guo JX, Fu PC, Huang XH, et al. A Clinical Study on Juheli (Recombinant Human Interleukin- 11) in the Second Prevention of Chemotherapy Induced Thrombocytopenia. Asian Pac J Cancer Prev. 2016;17(2):485-9.

Lei W, Liang J, Chen WG, Ma XZ, Xu M, Du LL. Effectiveness and safety of recombinant human interleukin-11 in the treatment of chemotherapy-induced thrombocytopenia. Zhonghua Zhong Liu Za Zhi. 2006;28(7):542-4.

Kuter DJ. What is the potential for thrombopoietic agents in acute leukemia? Best Pract Res Clin Haematol. 2011;24:553-8.

Kuter DJ. Managing thrombocytopenia associated with cancer chemotherapy. Oncology (Williston Park). 2015;29(4):282-94.

Ong H, Chua S and Milow P. Ethno-medicinal plants used by the Temuan villagers in KampungJeram Kedah Negeri Sembilan Malaysia. Ethno Med. 2011;5:95-100.

Sathasivam K, Ramanathan S, Mansor SM, Haris MR and Wernsdorfer WH. Thrombocyte count in mice after administration of papaya leaf suspension. Wien Klin Wochenschr. 2009;121:19-22.

Dharmarathna SLCA, Wickramasinghe S, Waduge RN, Rajapakse RPVJ, Kularatne SAM. Does Carica papaya leaf-extract increase the platelet count? An experimental study in a murine model. Asian Pacific J Tropical Biomed. 2013;3(9):720- 4.

Yadav J et al. Effect of Carica Papaya Leaf Extract On Platelet Count In Dengue Patient. Int J Recent Sci Res. 2017;8(11):21762-5.

Gadhwal AK, Ankit BS, Chahar C, Tantia P, Sirohi P, Agrawal RP. Effect of Carica papaya Leaf Extract Capsule on Platelet Count in Patients of Dengue Fever with Thrombocytopenia. J Assoc Physicians India. 2016;64(6):22-6.

Saha S, Ghosh S. Tinospora cordifolia:One plant, many roles. Ancient Science of Life. 2012;31(4):151-9.

Chauhan DS, Lata S, Sharma RK, Jindal M, Gupta AK, Suman A, Rehman S, Malik P. Evaluation of role of Tinospora Cordifolia (T.cord.) in experimentally induced (busulfan induced) thrombocytopenia in rabbits. Paripex-Indian J Res. 2016;5(6).

Sundarmurthy D, Jayanthi CR, Lakshmaiah KC. Effect of Carica papaya leaf extract on platelet count in chemotherapy-induced thrombocytopenic patients: A preliminary study. Natl J Physiol Pharm Pharmacol. 2017;7(7):685-92.

Chinnappan S, Ramachandrappa VS, Tamilarasu K, Krishnan UM, Pillai AK, Rajendiran S. Inhibition of Platelet Aggregation by the Leaf Extract of Carica papaya During Dengue Infection: An in Vitro Study. Viral Immunol. 2016;29(3):164-8.

Panda AK, Bhuyan G, Dattatray D, Rao MM. Phytoextracts of carica papaya and Tinospora cordifolia can correct thrombocytopenia in alcoholic decompensate liver cirrhosis:case series. Ayurveda Integr Med Sci. 2018;1:99-101.

Downloads

Published

2018-10-24

Issue

Section

Original Research Articles