UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053654 |
|---|---|
| Receipt number | R000061235 |
| Scientific Title | The Effect of Electroacupuncture Stimulation at Zusanli (ST36) on Blood Endotoxin Tolerance |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2024/02/20 01:04:29 |
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Basic information
Public title
Effect of Electroacupuncture Stimulation on Zusanli (ST36) on Immune Response
Acronym
The Immunological Effects of Electroacupuncture Stimulation at Zusanli (ST36)
Scientific Title
The Effect of Electroacupuncture Stimulation at Zusanli (ST36) on Blood Endotoxin Tolerance
Scientific Title:Acronym
"Does Electroacupuncture Stimulation at Zusanli (ST36) Alter the Immune Response in the Blood?
Region
| Japan |
Condition
Condition
Endotoxin plasma, allergies, and other diseases involving endotoxins.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of electroacupuncture stimulation at Zusanli (ST36) on LPS response in humans.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration of TNF-a secreted after LPS is added to whole blood, following blood collection four days after the commencement of electroacupuncture stimulation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Insert a 0.2mm diameter needle 2-3mm into Zusanli (ST36) and leave it in place for 15 minutes. This is done once a day for a total of four days.
Interventions/Control_2
Insert a 0.2mm diameter needle 25mm deep into Zusanli (ST36) and apply electroacupuncture stimulation for 15 minutes. The electroacupuncture stimulation is conducted at 2Hz for 15 minutes. This is done once a day for a total of four days.
Interventions/Control_3
"Insert a 0.2mm diameter needle 25mm deep into a point 3cm lateral to Zusanli (ST36) and apply electroacupuncture stimulation for 15 minutes. The electroacupuncture stimulation is conducted at 2Hz for 15 minutes. This is done once a day for a total of four days.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals not on medication.
Individuals without a habit of exercising three times a week or more.
Individuals who will not consume excessive alcohol during the experiment.
Individuals who have not received vaccines that affect the LPS response.
Key exclusion criteria
Individuals who cannot consent to participate in the experiment.
Individuals who cannot participate for the consecutive days required.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Komine |
| Middle name | |
| Last name | Shoichi |
Organization
Teikyo Heisei University
Division name
Faculty of Human Health, Department of Acupuncture and Moxibustion
Zip code
170-8445
Address
2-51-4, Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-4860
s.komine@thu.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Komine |
Organization
Teikyo Heisei University
Division name
Faculty of Human Health, Department of Acupuncture and Moxibustion
Zip code
170-8445
Address
2-51-4, Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-4860
Homepage URL
s.komine@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo Heisei University
Address
2-51-4, Higashi-Ikebukuro, Toshima-ku, Tokyo
Tel
03-5843-4860
s.komine@thu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R02-090
Org. issuing International ID_1
Teikyo Heisei University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 20 | 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
99
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
| 2021 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061235
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| Registered date | File name |
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