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Cold tablet (OTC medicine) effects on driving performance and safety: A randomized trial through driving simulation

Cold Tablet (OTC Medicine) Effects on Driving Performance and Safety: A Randomized Trial through Driving Simulation (in Open Volunteers and Based on Inclusion Criteria)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250415065334N1
Enrollment
24
Registered
2025-04-23
Start date
2025-07-23
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Cold tablet (over the counter medicine) effects on driving performance and safety.

Interventions

Intervention group: The current study is a double-blind, randomized, crossover clinical trial. Random allocation will be performed using block randomization with fixed block sizes (two 12-trial blocks
such that participants will receive two tablets in each of the three driving stages, and these two tablets will be in the form of: a) two placebo tablets, b) one cold tablet and one placebo tablet, an

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Individuals aged 20 to 60 years Having valid driver's license and a driving record of at least 6 months on various routes within and outside the city. Having no chronic or acute illness affecting driving performance and safety Not taking sedative medication and foods, hypnotic, and stimulants (such as sedative-hypnotics, sedative herbal medicines, significant caffeine, etc.) a few days before the test Getting enough sleep the night before the test Volunteering of an individual to participate in the study

Exclusion criteria

Exclusion criteria: individual's mismatch with the testing environment (such as the driving simulator) The volunteer's Inability to continue participation in the study

Design outcomes

Primary

MeasureTime frame
Standard Deviation of Lateral Position (SDLP). Timepoint: About two hours after the intervention (administration of the drug or placebo) and during the driving simulator test. Method of measurement: Software and sensors embedded in the Sahand-1 driving simulator system.;Standard Deviation of Speed (SDS). Timepoint: About two hours after the intervention (administration of the drug or placebo) and during the driving simulator test. Method of measurement: Software and sensors embedded in the Sahand-1 driving simulator system.

Secondary

MeasureTime frame
Reaction Time (RT). Timepoint: About two hours after the intervention (administration of the drug or placebo) and during the driving simulator test. Method of measurement: Software and sensors embedded in the Sahand-1 driving simulator system.;Lane Departure. Timepoint: About two hours after the intervention (administration of the drug or placebo) and during the driving simulator test. Method of measurement: Software and sensors embedded in the Sahand-1 driving simulator system.;Reaching a Specific Speed. Timepoint: About two hours after the intervention (administration of the drug or placebo) and during the driving simulator test. Method of measurement: Software and sensors embedded in the Sahand-1 driving simulator system.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Abolghasemi Fakhri

Tabriz University of Medical Sciences

mh.afakhri29@gmail.com+98 41 3380 0568

Outcome results

None listed

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