Perspectives in Clinical Research

ORIGINAL ARTICLE
Year
: 2014  |  Volume : 5  |  Issue : 2  |  Page : 71--74

Effects of botropase on clotting factors in healthy human volunteers


Ashok K Shenoy1, KV Ramesh1, Mukta N Chowta1, Prabha M Adhikari2, UP Rathnakar1 
1 Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India
2 Department of Medicine, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India

Correspondence Address:
Mukta N Chowta
Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore - 575 001, Karnataka
India

Objective: To evaluate the effects of botropase on various clotting factors in human volunteers. Materials and Methods: It was a prospective open label study conducted on human healthy volunteers. After the baseline screening, subjects fulfilling inclusion criteria were enrolled. On the study day, 1 ml of botropase was administered intravenously and after an hour same dose of botropase (1 ml) was given by intramuscular (IM) route. The efficacy and safety parameters were monitored up to 72 h from the time of intravenous (IV) administration. Results: A total of 15 volunteers, belonging to 24-35 years of age were included in the study. Botropase significantly reduced the plasma level of fibrinogen and fibrin degradation products after 5 min of IV administration (P < 0.05). In addition, factor X was observed to reduce constantly by botropase administration suggesting enhanced turnover between 5 and 20 min of IV administration. Although botropase reduced clotting and bleeding time in all the volunteers, the data remains to be statistically insignificant. Conclusion: Present study demonstrated the safety and efficacy of botropase in human healthy volunteers. The study has shown that it is a factor X activator and reduces effectively clotting and bleeding time.


How to cite this article:
Shenoy AK, Ramesh K V, Chowta MN, Adhikari PM, Rathnakar U P. Effects of botropase on clotting factors in healthy human volunteers.Perspect Clin Res 2014;5:71-74


How to cite this URL:
Shenoy AK, Ramesh K V, Chowta MN, Adhikari PM, Rathnakar U P. Effects of botropase on clotting factors in healthy human volunteers. Perspect Clin Res [serial online] 2014 [cited 2022 Aug 8 ];5:71-74
Available from: https://www.picronline.org/article.asp?issn=2229-3485;year=2014;volume=5;issue=2;spage=71;epage=74;aulast=Shenoy;type=0