Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05877079
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2023-05-14
Brief Title:
TRPM8 in Acute Ischemic Stroke by Topical Menthol
Sponsor:
Taipei Medical University Hospital
Organization:
Taipei Medical University Hospital
Study Overview
Official Title:
Activation of Peripheral TRPM8 Mitigates Acute Ischemic Stroke by Topically Applied Menthol
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ww 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
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 ww 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
Detailed Description:
Sixty patients with acute ischemic stroke were randomly divided into two groups thirty in the treatment group and thirty in the control group
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 After completing the basic assessments and signing the informed consent participants will be randomly allocated to either the treatment group or the control group for the trial
The treatment group will use an emulsion containing 8 ww menthol with an average of 80 grams placed inside hand and foot wraps 20 grams in each hand or foot wrap Participants will wear the wraps for five minutes before removal This process will be done once a day for five consecutive days in a week followed by two days of rest and will last for four weeks
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 The same procedure will be followed participants will wear the wraps for five minutes before removal once a day for five consecutive days in a week followed by two days of rest for a total of four weeks
All participants will be re-evaluated after the fourth and eighth weeks of the trial with assessments including neurological examination NIHSS BI and mRS
Emergency neurology outpatient and inpatient participants will also use the 8 ww menthol emulsion with an average of 80 grams placed inside hand and foot wraps 20 grams each The same procedure will be followed wearing the wraps for five minutes before removal once a day for five consecutive days per week followed by two days of rest for a total of four weeks
Participants will be evaluated within seven days after being diagnosed with a stroke and then again after the fourth and eighth weeks of treatment The evaluations will include neurological examination NIHSS BI and mRS assessments
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 After completing the basic assessments and signing the informed consent participants will be randomly allocated to either the treatment group or the control group for the trial
The treatment group will use an emulsion containing 8 ww menthol with an average of 80 grams placed inside hand and foot wraps 20 grams in each hand or foot wrap Participants will wear the wraps for five minutes before removal This process will be done once a day for five consecutive days in a week followed by two days of rest and will last for four weeks
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 The same procedure will be followed participants will wear the wraps for five minutes before removal once a day for five consecutive days in a week followed by two days of rest for a total of four weeks
All participants will be re-evaluated after the fourth and eighth weeks of the trial with assessments including neurological examination NIHSS BI and mRS
Emergency neurology outpatient and inpatient participants will also use the 8 ww menthol emulsion with an average of 80 grams placed inside hand and foot wraps 20 grams each The same procedure will be followed wearing the wraps for five minutes before removal once a day for five consecutive days per week followed by two days of rest for a total of four weeks
Participants will be evaluated within seven days after being diagnosed with a stroke and then again after the fourth and eighth weeks of treatment The evaluations will include neurological examination NIHSS BI and mRS assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None