To assess the safety of mosquito repellent red coil (metofluthrin) in human volunteers.

A prospective, non-comparative, multi-center, post marketing surveillance study in human volunteers, among inmates of households exposed to 0.005%w/w Metofluthrin Red coil in single zone for duration of one year.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/05/042355

Enrollment

120

Registered

2022-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

None listed

Interventions

Intervention1: 0.005% w/w Metofluthrin Red coil: 0.005%w/w Red mosquito repellent coil used on daily basis for 12 hours for 365 consecutive nights. Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1) Written informed consent from the subject. 2) Age more than 12 years completed.

Exclusion criteria

Exclusion criteria: 1) Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion. 2) Pregnancy 3) Lactation 4) Chronic respiratory disorder 5) Simultaneous participation in any other trial

Design outcomes

Primary

Measure	Time frame
1) Change from baseline in vital signs. 2) Change from baseline in clinical chemistry, urine analysis and haematology. 3) Adverse events reporting.Timepoint: 90, 180, 365 days	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Service

milansatia@ethicare-cro.com9825585119

Outcome results