To determine the clinical effectiveness and safety of a local application of Inj Reptilase in patients with bleeding of respiratory and upper digestive tract
Phase 4
Completed
- Conditions
- Health Condition 1: null- Upper Aero digestive tract hemorrhages
- Registration Number
- CTRI/2008/091/000208
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients in the age group of 18 -60 years
Patients of both sexes
Patients with upper aero digestive tract hemorrhage either spontaneous or post office biopsy procedure
Exclusion Criteria
Patients below 18 years and above 60 years of age
Patients with compromised vital organ function
Haemodynamically unstable patients.
Pregnant and lactating women.
Mentally retarded patients
Unwilling patients
Patients with known hypersensitivity to any component of the formulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to onset of haemostasisTimepoint: 10 minutes following application
- Secondary Outcome Measures
Name Time Method Global efficacy by patients and investigator.Timepoint: 24 hours;No. of patients needing additional management to arrest bleedingTimepoint: 10 minutes;Time to recurrence of bleeding (if any)Timepoint: Up to 24 hours