UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049593 |
|---|---|
| Receipt number | R000056199 |
| Scientific Title | Exploring biomarkers associated with acupuncture-induced changes in human salivary components and stress relief. |
| Date of disclosure of the study information | 2022/11/23 |
| Last modified on | 2022/11/23 19:05:40 |
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Basic information
Public title
Research to search biomarkers that can objectively evaluate "stress relief" utilization variation data in the concentration of components in saliva collected before and after the acupuncture treatment.
Acronym
Research to Search Biomarkers Associated with Acupuncture and Stress Relief
Scientific Title
Exploring biomarkers associated with acupuncture-induced changes in human salivary components and stress relief.
Scientific Title:Acronym
Exploring Biomarkers Associated with Acupuncture treatment and Stress Relief
Region
| Japan |
Condition
Condition
Rehabilitations
Classification by specialty
| Rehabilitation medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore biomarkers associated with acupuncture-induced changes in human salivary components and stress relief.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study searchs the indicator substances from salivary components (organic molecules, electrolytes, etc.) that show a strong correlation with cerebral blood flow, which fluctuates before and after acupuncture stimulation.
Key secondary outcomes
The explored indicator substances will be extensively examined from the viewpoints of neurology, physiology and immunology.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group 1: control group (Acupuncture needles, but not electricity)
Interventions/Control_2
Group 2: 100 HZ-0.2 mA MST (EA) stimulation group
Interventions/Control_3
Group 3: 100 HZ-1.0 mA EA Stimulation group
Interventions/Control_4
Group 4: 100 HZ-2.0 mA EA Stimulation Stimulation Cluster: 10
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
The preliminary study (exercise stimulus) at Kochi University is conducted with healthy subjects (20 years and older) who have never smoked. In addition, an exercise protocol (jump rope) is introduced and implemented, which was found to cause fluctuations in blood and saliva components in a preliminary literature review.
Prof. Tatsuya Hisajima, Teikyo Heisei University, randomly selects healthy subjects over 20 years old who are undergo electroacupuncture stimulation, saliva collection before and after the stimulation, and a medical questionnaire. On the day of the session, the participants will undergo a health checkup, and then undergo electroacupuncture stimulation at the trigeminal nerve in the frontal lobe, saliva sampling, and a medical questionnaire.
Key exclusion criteria
1.Those who are currently receiving drug treatment for any diseases (except for headache, common cold, etc.).
2.Those who are currently in the habit of taking or applying drugs.
3.Those who have hypersensitive scalp.
4. Those with a history or current history of hypertension, dyslipidemia, or diabetes mellitus.
5. Those with a history or current history of heart failure, renal failure, hepatitis B or hepatitis C
6. Those with a history or current history of serious disorders of the liver, kidneys, heart, lungs, blood, etc.
7. Those who sleep short hours (less than 5 hours a day) or long hours (more than 10 hours a day).
8. Those who have irregular or reversed day and night life due to work or part-time job.
9. Those with a BMI (kg/m2) of 30 or higher.
10. Those who drink more than 60g of alcohol/day on average on a daily basis.
11. Smokers.
12. Those who are likely to change their lifestyle during the study period (e.g., long trips, etc.).
13. Patients who need to take medication during the study period.
14. Currently participating in another human clinical trial, or not yet 3 months have passed since participation in another human clinical trial.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Mori |
Organization
Kochi University
Division name
Faculty of Science and Technology
Zip code
780-8520
Address
2-5-1, Akebono-cho, Kochi-city, Kochi
TEL
088-844-8306
mori@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Mori |
Organization
Kochi University
Division name
Faculty of Science and Technology
Zip code
780-8520
Address
2-5-1, Akebono-cho, Kochi-city, Kochi
TEL
088-844-8306
Homepage URL
mori@kochi-u.ac.jp
Sponsor or person
Institute
Faculty of Science and Technology, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Kochi University
Address
2-5-1, Akebono-cho, Kochi-city, Kochi
Tel
088-844-8306
mori@kochi-u.ac.jp
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
| 2022 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 23 | Day |
Last modified on
| 2022 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056199
