To determine the clinical effectiveness and safety of a local application of Inj Reptilase in patients with bleeding of respiratory and upper digestive tract

An open label, randomized placebo controlled study evaluating the efficacy and safety of a topical application of inj Reptilase in patients with upper aero digestive tract hemorrhage.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000208

Enrollment

Registered

2008-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Upper Aero digestive tract hemorrhages

Interventions

Intervention1: Injection Reptilase 1 NIH/ml: Single topical application at site of bleeding Control Intervention1: Placebo: Single topical application at site of bleeding

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Time to onset of haemostasisTimepoint: 10 minutes following application	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

Vice President, Medical Services

Vijayajaiswal@troikaapharma.com079-26856242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026