A Clinical Trial to study effect of heparin sodium topical solution in prevention of infusion associated phlebitis.

A prospective, randomized, double blind, placebo controlled, parallel group, multicenter, clinical study to evaluate safety and efficacy of Phlebotroy QPS (heparin sodium topical solution) 1000 IU/ ml in prevention of infusion associated phlebitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008263

Enrollment

374

Registered

2017-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: null- patients undergoing cannulation of peripheral vein that has been planned to remain in situ for at least 72 hours of indoor period

Interventions

Intervention1: Phlebotroy QPS (heparin sodium topical solution) 1000 IU/ ml: Each ml (approximately 34 drops) of topical solution contains 1000 IU equivalent heparin sodium.6 to 8 drops of solution ap

Eligibility

Inclusion criteria

Inclusion criteria: 1.Either gender, age 18 to 65 years, both inclusive 2.Undergoing peripheral vein cannulation that has been planned to remain in situ for at least 72 hours of indoor period 3.Willing & able to comply with study requirements, e.g. regular application of IP and efficacy-safety evaluation schedule, as indicated by written informed consent provided by the patient. 4.If female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing to maintain reliable birth control throughout the study.

Exclusion criteria

Exclusion criteria: 1.Undergoing re-cannulation due to phlebitis at earlier cannulation site 2.Unconscious or comatose patients 3.History of hypersensitivity reaction to heparin or heparin induced thrombocytopenia 4.Planned administration of any of the following during study period: ? Anti-coagulants locally (at IV site or in the cannula) or systemically ? NSAIDs locally at IV site 5.Patients having participated in any clinical trial within last 30 days at the time of screening 6.Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome

Design outcomes

Primary

Measure	Time frame
Incidence of infusion phlebitis (grade II & above) during 72 hours of treatment periodTimepoint: [every 8±1 hours for 72 hours starting within 1 hour of cannulation, total 10 times	—

Secondary

Measure	Time frame
1. Mean time to develop infusion phlebitis (grade II or above) in hours. For patients not reaching grade II by 72 hours, it will be 72 hours. 2. Mean maximum intensity of pain experienced by patients at IV site recorded on 100 mm Visual Analogue Scale (VAS) during 72 hours of treatment period. 3. Incidence of first signs of phlebitis (grade I) 4. Mean time to develop infusion phlebitis grade I (or above) in hoursTimepoint: [every 8±1 hours for 72 hours starting within 1 hour of cannulation, total 10 times]:	—

Measure

Time frame

1. Mean time to develop infusion phlebitis (grade II or above) in hours. For patients not reaching grade II by 72 hours, it will be 72 hours. 2. Mean maximum intensity of pain experienced by patients at IV site recorded on 100 mm Visual Analogue Scale (VAS) during 72 hours of treatment period. 3. Incidence of first signs of phlebitis (grade I) 4. Mean time to develop infusion phlebitis grade I (or above) in hoursTimepoint: [every 8±1 hours for 72 hours starting within 1 hour of cannulation, total 10 times]:

—

Countries

India

Contacts

Public ContactDr Amarinder Singh

Troikaa Pharmaceuticals Limited

amarindersingh@troikaapharma.com9099905926

Outcome results

None listed

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