title: Effects of botropase on clotting factors in healthy human volunteers.
abstract: OBJECTIVE
  To evaluate the effects of botropase on various clotting factors in human volunteers.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors.forename: Ashok K
authors.initials: AK
authors.lastname: Shenoy
authors.affiliation: Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors.forename: K V
authors.initials: KV
authors.lastname: Ramesh
authors.affiliation: Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors.forename: Mukta N
authors.initials: MN
authors.lastname: Chowta
authors.affiliation: Department of Medicine, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors.forename: Prabha M
authors.initials: PM
authors.lastname: Adhikari
authors.affiliation: Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors.forename: U P
authors.initials: UP
authors.lastname: Rathnakar
keywords: Botropase; clotting factors; fibrinogen; hemocoagulase
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