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

March 15, 2026 updated by: A. Andi Kurniawan, Taisho Pharmaceutical Indonesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 12940
        • Eminence Elite Clinic - Elite Club

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults, 18 - 45 years old
  • Have a personal best 10-kilometer run time of under one hour (which will be confirmed during the screening of prospective Subjects through history taking) in the last 6 months.
  • Doing running training at least 3 times/week for the past 1 year
  • Have a level of heart-lung endurance or VO2max that is at least included in the average criteria (known through examination: Bleep test)
  • Meets Subject screening criteria by answering "No" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) questionnaire.
  • Have normal resting ECG and normal GDS results on screening of prospective Subjects.
  • At the time of the study, the body temperature was within the normal range

Exclusion Criteria:

  • Pregnant and/or breastfeeding women
  • Have had a musculoskeletal injury in the last three months and still have symptoms or complaints
  • Are experiencing acute infectious disorders, such as gastrointestinal, respiratory infections
  • During treatment for chronic diseases (e.g. high blood pressure or hypertension, diabetes or diabetes mellitus, heart disease)
  • Have a history of hypersensitivity or allergy to menthol or skin-applied products (especially gel-based products)
  • Has a history of cold allergy
  • Have a positive COVID-19 test result at the time of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Placebo: light blue gel where the active ingredient Menthol is replaced by purified water.
Other: Placebo
Light blue gel where the active ingredient Menthol is replaced by purified water.
Experimental: Menthol Group
Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Thermal Sensation
Time Frame: Baseline (pre-run), during run (~20 minutes), and immediately post-run (within 5 minutes after running completion).
Assessed using a 7-point thermal sensation scale. The scale ranges from -3 to +3, where -3 represents "cold", 0 represents "neutral", and +3 represents "hot". A higher score indicates a greater sensation of heat.
Baseline (pre-run), during run (~20 minutes), and immediately post-run (within 5 minutes after running completion).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Rating of Perceived Exertion (RPE)
Time Frame: Immediately post-run (within 5 minutes after running completion).
Assessed using the Borg Rating of Perceived Exertion (RPE) scale. The scale ranges from 6 to 20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion". Higher scores represent a greater perceived physical effort by the participant.
Immediately post-run (within 5 minutes after running completion).
Change in Tympanic Temperature
Time Frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Measured in degrees Celsius (°C) using a tympanic thermometer to evaluate thermoregulation and core body temperature changes in response to the running exercise and cooling intervention
Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Running Duration
Time Frame: Post-run (within 5 minutes after running completion).
Running duration was calculated as the time the subject took to complete a 5-kilometer run (in minutes) using a digital pocket sports stopwatch
Post-run (within 5 minutes after running completion).
Change in Perceived Comfort
Time Frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
To evaluate perceived comfort, participants used a scale that included the options: "comfortable," "somewhat uncomfortable," "uncomfortable," and "extremely uncomfortable
Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Change in Hydration Status
Time Frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Hydration status, categorized as "well-hydrated," "mildly dehydrated," or "dehydrated,". Pre run hydration status was assessed by matching urine color to a color chart. Post run hydration status was assessed through percentage body weight (BW) loss
Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Change in Heart Rate
Time Frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Measured in beats per minute (bpm) was measured using a Polar Heart Rate Monitor to evaluate cardiovascular strain and physical intensity during the running exercise. This will include assessing the mean heart rate and the highest heart rate frequency.
Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taisho Pharmaceutical Indonesia

Collaborators

Trisakti University
Atma Jaya Catholic University of Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP.Mentol-V004/V/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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