# A Multicentric, Prospective, Observational, Single-Arm Registry Study to Assess the Clinical Safety and Effectiveness of Thrombophob Ointment (Heparin Sodium + Benzyl Nicotinate) in Indian Patients With Thrombophlebitis

## TL;DR

This study evaluated a topical ointment containing heparin and benzyl nicotinate for treating thrombophlebitis in Indian patients and found it to be safe and effective.

## Contribution

The study provides real-world evidence of the safety and effectiveness of a specific ointment for thrombophlebitis in an Indian population.

## Key findings

- Patients showed significant improvement in phlebitis severity, lesion length, and pain scores by day 3 and day 7.
- Treatment effectiveness was excellent in 72% of patients, and safety was excellent in 93%.
- Adverse effects were minimal, with only 0.25% and 0.05% of patients reporting issues on day 3 and day 7, respectively.

## Abstract

Purpose

Thrombophlebitis is a frequent intravenous (IV) therapy consequence. Topical heparin for seven days is used as a treatment for thrombophlebitis. This study was performed to evaluate the clinical safety and effectiveness of the combination of heparin sodium & benzyl nicotinate (Thrombophob Ointment, manufactured by Zydus Healthcare Ltd., Ahmedabad, India) in thrombophlebitis patients in India.

Methods

A study carried out by 118 Indian doctors examined 2002 thrombophlebitis patients from 2016-2023, prescribing ointment containing heparin sodium and benzyl nicotinate. Patients were followed up on day three and day seven after starting the treatment, and safety and effectiveness were recorded, including adverse events.

Result

A total of 2002 patients were included in the study and males were predominant (58.15%). IV fluids (60.58%) were the leading cause of thrombophlebitis. The study found notable improvements in key markers of venous health over time. Compared to baseline, patients experienced significantly reduced severity of phlebitis, shorter venous lesion lengths, and lower pain and tenderness scores by both day 3 and day 7 (p<0.001 for all comparisons). Furthermore, these improvements continued between day 3 and day 7, indicating sustained positive effects (p<0.001 for all comparisons). After the application of the ointment, very few patients experienced adverse effects (0.25% on day three and 0.05% on day seven). Treatment effectiveness was excellent in 72% of patients, and treatment safety was excellent in 93% of patients.

Conclusion

The ointment containing heparin sodium and benzyl nicotinate was well tolerated and efficacious in the treatment of thrombophlebitis in Indian patients.