UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020071 |
|---|---|
| Receipt number | R000023185 |
| Scientific Title | Effect of electroacupuncture treatment for itching and skin condition of patients with atopic dermatitis |
| Date of disclosure of the study information | 2015/12/04 |
| Last modified on | 2015/12/04 13:11:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of electroacupuncture treatment for itching and skin condition of patients with atopic dermatitis
Acronym
Effect of electroacupuncture treatment for itching and skin condition of patients with atopic dermatitis
Scientific Title
Effect of electroacupuncture treatment for itching and skin condition of patients with atopic dermatitis
Scientific Title:Acronym
Effect of electroacupuncture treatment for itching and skin condition of patients with atopic dermatitis
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We consider the effect of electroacupuncture treatment on Atopic Dermatitis with itching and skin condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity of itching(Visual Analogue Scale)
severity of atopic dermatitis(Patient Oriented SCORAD)
stratum corneum TARC level
skin barrier(TEWL, stratum corneum water content)
QOL of patients(Skindex-16)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to the standard treatment, electroacupuncture stimulation(100Hz) to LI11, LI10, ST36, and ST37 for 15min once a week for 10 weeks.
Interventions/Control_2
standard treatment only
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
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
Adult patients with atopic dermatitis and agreement on this study.
Key exclusion criteria
patients treated with systemic treatment
pregnant woman
cases who are judged to discourage by attending principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Egawa |
Organization
Meiji University of Oriental Medicine
Division name
Department of Geriatric Acupuncture and Moxibution
Zip code
Address
Hiyoshi-cho, Nantan-shi, Kyoto, Japan 629-0392
TEL
0771-72-1181
e_egawa@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Egawa |
Organization
Meiji University of Oriental Medicine
Division name
Department of Geriatric Acupuncture and Moxibution
Zip code
Address
629-0392
TEL
0771-72-1181
Homepage URL
e_egawa@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Oriental Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji University of Oriental Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 12 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 04 | 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
| 2015 | Year | 12 | Month | 04 | Day |
Last modified on
| 2015 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023185
