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NCT05877079CompletedPhase 2

TRPM8 in Acute Ischemic Stroke by Topical Menthol

Activation of Peripheral TRPM8 Mitigates Acute Ischemic Stroke by Topically Applied Menthol

Source: ClinicalTrials.gov · Last updated 15 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (actual)
First submitted
14 May 2023
Start date
26 May 2023
Primary completion date
3 Jun 2024
Lead sponsor
Taipei Medical University Hospital
Diseases
Stroke
NCT number
NCT05877079

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 60
  • From 26 May 2023 to the primary completion date, 3 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • NIHSS score does not meet, mRS=5, patients who cannot cooperate, moderate to severe brain trauma, pregnant women, uremia, liver cirrhosis, heart failure with pulmonary edema and coagulation dysfunction, epilepsy, alcohol, drug abuse. Participants were ranked by the investigator as unsuitable for the study.

Who the study is looking for

  • Acute ischemic stroke patients, stroke time within one week, those who are legally of age at the time of signing the consent form, NIHSS 4-20, patients who can cooperate with treatment, Self or agent agrees to sign the consent form.

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Taipei Medical University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.