UMIN-CTR Clinical Trial

Basic information
Public title	Effects and safety of acupuncture treatment with renal jinyuketsu stimulation on blood cytokines in healthy subjects: a randomized control open trial (phase I)
Acronym	Effects and safety of acupuncture treatment on blood cytokines in healthy subjects
Scientific Title	Effects and safety of acupuncture treatment with renal jinyuketsu stimulation on blood cytokines in healthy subjects: a randomized control open trial (phase I)
Scientific Title:Acronym	Effects and safety of acupuncture treatment with renal jinyuketsu stimulation on blood cytokines in healthy subjects: a randomized control open trial (phase I)
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Neurology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of acupuncture treatment with jinyuketu stimulation on blood cytokines and safety in healthy subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of serum IL-10 levels after acupuncture treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	acupuncture treatment with jinyuketsu
Interventions/Control_2	acupuncture treatment without jinyuketsu
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Of the subjects who applied for this study voluntarily and obtained consent before the study, they were healthy subjects aged 20 years or older at the time of obtaining consent, and were judged to be appropriate as subjects.
Key exclusion criteria	1) Subjects with a history of immune disease 2) Subjects with immune disease 3) Subjects with skin disease at treatment site 4) Subjects with a history of decreased blood pressure or syncope due to acupuncture treatment 5) Subjects with steroid or immunosuppressants Others who are considered inappropriate by the investigators
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Akiyuki Middle name Last name Uzawa
Organization	Graduate School of Medicine, Chiba University
Division name	Neurology
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2129
Email	auzawa@chiba-u.jp

Public contact
Name of contact person	1st name Akiyuki Middle name Last name Uzawa
Organization	Graduate School of Medicine, Chiba University
Division name	Neurology
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2129
Homepage URL
Email	auzawa@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
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	Chiba University
Address	1-8-1 Inohana, Chuo-ku, Chiba
Tel	043-222-7171
Email	prc-jim@chiba-u.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	2020 Year 01 Month 15 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	Completed
Date of protocol fixation	2019 Year 12 Month 03 Day
Date of IRB	2020 Year 02 Month 17 Day
Anticipated trial start date	2020 Year 02 Month 25 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 14 Day
Last modified on	2021 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044633