Clinical Trial

Effectiveness of Topical Menthol as A Cooling Method During Exercise in A Recreational Runner Population

Completed Phase 2/3
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Summary
The goal of this clinical trial is to evaluate the effectiveness of topical menthol as a cooling method during exercise in a hot air environment in healthy adult recreational runners aged 18 to 45 years. The main questions it aims to answer are: What is the difference in thermal sensation between the topical menthol gel application and a placebo during exercise? How does the application of topical menthol affect body temperature, heart rate, and physical performance compared to a placebo? Researchers will compare a 4% Menthol gel to a placebo gel in a cross-over design to see if the menthol gel improves thermal sensation, regulates body temperature, and enhances physical performance and comfort. Participants will: 1. Undergo a screening process including a medical history review, physical examination, resting ECG, blood sugar test, and a Bleep fitness test. 2. Participate in two separate running activities at an athletic field, separated by a wash-out period of 7 days + 1 day.Have the assigned gel (menthol or placebo) applied to their neck, front upper arms, and front upper legs while running (specifically between kilometers 2.5 and 2.8). 3. Complete pre-run and post-run assessments measuring weight, skin and tympanic temperature, heart rate, vertical jump height, running duration, perceived exertion (RPE), thermal sensation, and comfort.
Trial Details
NCT Number NCT07482046
Lead Sponsor Taisho Pharmaceutical Indonesia
Collaborators: Trisakti University, Atma Jaya Catholic University of Indonesia
Conditions Heat Stress, Athletic Performance
Enrollment 37 participants
Start Date 2023-05-30
Primary Completion 2023-10-20 (estimated)
Study Completion 2023-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-19