UMIN-CTR Clinical Trial

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
Email	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
Email	mori@kochi-u.ac.jp

Sponsor
Institute	Faculty of Science and Technology, Kochi University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056199