UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028798 |
|---|---|
| Receipt number | R000032957 |
| Scientific Title | The influence of herbs on pain threshold |
| Date of disclosure of the study information | 2017/08/23 |
| Last modified on | 2017/08/23 18:13:16 |
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Basic information
Public title
The influence of herbs on pain threshold
Acronym
The influence of herbs on pain threshold
Scientific Title
The influence of herbs on pain threshold
Scientific Title:Acronym
The influence of herbs on pain threshold
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of external application of herb (menthol) on skin sensation and pain threshold
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Three minutes after application of topical medicine, pain equivalent current value is measured by PainVision
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Menthol is applied to the inside of the forearm, and pain equivalent current value is measured with PainVision 3 and 10 minutes later (Menthol group)
Interventions/Control_2
Mentholatum group
Interventions/Control_3
Ethanol group
Interventions/Control_4
Menthol + Mentholatum group
Interventions/Control_5
Menthol + Ethanol group
Interventions/Control_6
Mentholatum + Ethanol group
Interventions/Control_7
Menthol + Mentholatum + Ethanol group
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adult
2.Subjects whose The American Society of Anesthesiologists physical status (ASA-PS) is 1 and 2.
3.Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria
1.Subjects who disagree to participate in this study.
2.Subjects who are allergic to menthol, mentholatum, ethanol.
3.Subjects with skin disorders such as atopic dermatitis
4.Subjects with complications of neurological disorders such as neurological diseases and severe diabetes
5.Subjects taking analgesics
6.Subjects conducting topical therapy to the forearm
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiko Ono |
Organization
Tohoku University
Division name
Department of Anesthesiology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
chura0728@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamauchi Masanori |
Organization
Tohoku University
Division name
Department of Anesthesiology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
Homepage URL
yamauchi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 23 | Day |
Last modified on
| 2017 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032957
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
