NCT07482046

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Taisho Pharmaceutical Indonesia · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heat Stress
• Athletic Performance

Interventions

Type	Name	Description
DRUG	Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.	The test drug, i.e. 4% Menthol gel or placebo, will be applied by rubbing on the neck area, the front side of the upper arm and the front side of the upper leg. The neck area was chosen because there is a carotid artery in the neck area, which is said to have an impact on changes in body temperature in the hypothalamus. In addition, the upper arm and upper leg areas were chosen because they are the extremity areas closest to the core of the body and perform a lot of movement while running. Some journals concluded that the application of cooling methods in the hand and thigh area is effective for cooling methods.
OTHER	Placebo	Light blue gel where the active ingredient Menthol is replaced by purified water.

Timeline

• Start date: 2023-05-30
• Primary completion: 2023-10-20
• Completion: 2023-12-31
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Indonesia