To assess the safety of mosquito repellent red coil (metofluthrin) in human volunteers.
Phase 4
Completed
- Registration Number
- CTRI/2022/05/042355
- Lead Sponsor
- Ms Sumitomo Chemical India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1) Written informed consent from the subject.
2) Age more than 12 years completed.
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Change from baseline in vital signs. <br/ ><br>2) Change from baseline in clinical chemistry, urine analysis and haematology. <br/ ><br>3) Adverse events reporting.Timepoint: 90, 180, 365 days
- Secondary Outcome Measures
Name Time Method ATimepoint: NA