To determine the effectiveness and safety of a local application of inj Reptilase in comparison with Inj Ethamsylate in the management of patients with nasal bleeds, spontaneous, post-operative or post biopsy.

An open label randomized study evaluating the efficacy and safety of a topical application of Inj Reptilase Vs Inj Ethamsylate in the management of epistaxis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000305

Enrollment

Registered

2009-03-26

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- Epistaxis, post-operative or post biopsy nasal bleeding.

Interventions

Intervention1: Injection Reptilase 1 NIH/ ml: Single topical application at site of bleeding Control Intervention1: Injection Ethamsylate 150 mg/ ml: 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 presenting with epistaxis/ post-operative / post biopsy nasal bleeding.

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/ guardians Patients with known hypersensitivity to any component of the formulation

Design outcomes

Primary

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

Secondary

Measure	Time frame
Global efficacy by patients and investigator.Timepoint: 48 hours;Number of patients needing additional therapy to arrest bleedingTimepoint: At the end of 10 minutes following topical application	—

Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

Vijayajaiswal@troikaapharma.com07926856242

Outcome results

None listed

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