drugset / Trial / NCT05877079

TRPM8 in Acute Ischemic Stroke by Topical Menthol

NCT05877079

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

Our previous results suggested that activation of peripheral TRPM8 expressed in the derma tissue of limbs with sufficient concentration of menthol is beneficial to stroke recovery. In the present study, sixty patients with acute ischemic stroke were randomly divided into two groups: thirty in the treatment group and thirty in the control group. The treatment group will use an emulsion containing 8% w/w menthol, with an average of 80 grams placed inside hand and foot wraps (20 grams in each hand or foot wrap). The control group, on the other hand, will use an emulsion that does not contain any menthol, with an average of 80 grams placed inside hand and foot wraps. Participants in this study will initially undergo a detailed regular neurological examination, an assessment with the National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI) for daily living functions, and the Modified Rankin Scale (mRS) for disability. All participants will be re-evaluated after the fourth and eighth weeks of the trial, with assessments including neurological examination, NIHSS, BI, and mRS.

Timeline

Start
2023-05-26
Primary completion
2024-06-03
Completion
2024-06-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Menthol Small molecule 8 % Topical

Indications