UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039152 |
|---|---|
| Receipt number | R000044633 |
| 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) |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2021/07/16 09:18:12 |
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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
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
auzawa@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044633
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
