To determine the efficacy and safety of 1000 IU/ ml topical solution of heparin sodium versus 200 IU/G heparin sodium gel in the management of post infusion superficial thrombophlebitis.

A randomized comparative study evaluating the efficacy and tolerability of a 1000 IU/ml topical solution of heparin sodium as compared to a 200 IU/G heparin sodium gel in the management of post infusion superficial thrombophlebitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002947

Enrollment

200

Registered

2010-11-08

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- Post infusion superficial thrombophlebitis.

Interventions

Intervention1: Heparin sodium 1000 IU/G solution: Heparin solution should be applied in a thin layer in an amount sufficient to cover the phlebitic lesion 3 times daily (morning, noon and evening).Tre

Eligibility

Inclusion criteria

Inclusion criteria: a)Patients in the age group of 18-60 years b)Patients of both sexes c)Patients on IV infusion d)Superficial thrombophlebitis Grade 2-4

Exclusion criteria

Exclusion criteria: a)Patients below 18 years and above 60 years of age b)Patients on anticoagulants c)Pregnant and lactating women d)Patients with any contraindication to heparin e)Mentally retarded patients f)Unwilling patients g)Patients with known hypersensitivity to any component of the formulation h)Patients with grade 1 or 5 phlebitis i)Application of other topical anti-inflammatory agent.

Design outcomes

Primary

Measure	Time frame
1.Local Symptoms (Score of Pain, Score of tenderness, Score of redness, Score of raised local temperature, Score of venous induration) 2.Change in length of the venous lesion in millimeters. 3.Change in the grade of the lesion 4.Time taken to reach end point 5.Status of lesion at day 7Timepoint: 1. At Baseline and day 3 2. At Baseline and day 3 3. At Baseline and day 3 4. At day 3 and day 7 5. At day 7;1.Local Symptoms (Score of Pain, Score of tenderness, Score of redness, Score of raised local temperature, Score of venous induration) 2.Change in length of the venous lesion in millimeters. 3.Change in the grade of the lesion 4.Time taken to reach end point 5.Status of lesion at day 7Timepoint: 1. At Baseline and day 3 2. At Baseline and day 3 3. At Baseline and day 3 4. At day 3 and day 7 5. At day 7;1.Local Symptoms (Score of Pain, Score of tenderness, Score of redness, Score of raised local temperature, Score of venous induration) 2.Change in length of the venous lesion in millimeters. 3.Change in the grade of the lesion 4.Time taken to reach end point 5.Status of lesion at day 7Timepoint: 1. At Baseline and day 3 2. At Baseline and day 3 3. At Baseline and day 3 4. At day 3 and day 7 5. At day 7	—

Measure

Time frame

1.Local Symptoms (Score of Pain, Score of tenderness, Score of redness, Score of raised local temperature, Score of venous induration) 2.Change in length of the venous lesion in millimeters. 3.Change in the grade of the lesion 4.Time taken to reach end point 5.Status of lesion at day 7Timepoint: 1. At Baseline and day 3 2. At Baseline and day 3 3. At Baseline and day 3 4. At day 3 and day 7 5. At day 7;1.Local Symptoms (Score of Pain, Score of tenderness, Score of redness, Score of raised local temperature, Score of venous induration) 2.Change in length of the venous lesion in millimeters. 3.Change in the grade of the lesion 4.Time taken to reach end point 5.Status of lesion at day 7Timepoint: 1. At Baseline and day 3 2. At Baseline and day 3 3. At Baseline and day 3 4. At day 3 and day 7 5. At day 7;1.Local Symptoms (Score of Pain, Score of tenderness, Score of redness, Score of raised local temperature, Score of venous induration) 2.Change in length of the venous lesion in millimeters. 3.Change in the grade of the lesion 4.Time taken to reach end point 5.Status of lesion at day 7Timepoint: 1. At Baseline and day 3 2. At Baseline and day 3 3. At Baseline and day 3 4. At day 3 and day 7 5. At day 7

—

Secondary

Measure	Time frame
Local and Systemic Adverse eventsTimepoint: Throughout the study;Patients global evaluationTimepoint: Day 7 (At the end of the study);Physicians global evaluation. Timepoint: Day 7 (At the end of the study)	—

Countries

India

Contacts

Public ContactDr Sanjay Maroo

Troikaa Pharmaceuticals Limited

medicalservices@troikaapharma.com079-26856242

Outcome results

None listed

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