UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054810 |
|---|---|
| Receipt number | R000061938 |
| Scientific Title | "Observational Study on the Effects of Contact Needle Therapy on Biological Information by Comparing Before and After Treatment and Between Treated and Untreated Groups" |
| Date of disclosure of the study information | 2024/06/30 |
| Last modified on | 2025/07/14 10:14:00 |
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Basic information
Public title
"Observational Study on the Effects of Contact Needle Therapy on Biological Information by Comparing Before and After Treatment and Between Treated and Untreated Groups"
Acronym
Observational Study on the Effects of Contact Needles on Biological Information
Scientific Title
"Observational Study on the Effects of Contact Needle Therapy on Biological Information by Comparing Before and After Treatment and Between Treated and Untreated Groups"
Scientific Title:Acronym
Observational Study on the Effects of Contact Needles on Biological Information
Region
| Japan |
Condition
Condition
healthy women
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observational Study on the Effects of Contact Needle Application on Biological Information: A Pre- and Post-Intervention Comparison and a Comparison Between Intervention and Non-Intervention Groups
In this trial, healthy volunteers willing to participate in the study will be divided into two groups: a contact needle intervention group and a non-intervention group. For the contact needle intervention group, changes in internal biological information, will be collected and analyzed using various devices and conditions before and after the application of contact needles, and again two days later. In the non-intervention group, the same parameters will be measured on the day of examination and two days thereafter.
Basic objectives2
Others
Basic objectives -Others
Additionally, traditional Chinese medicine diagnoses will be conducted to assess the impact of contact needle application.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Contact Needle Techniques adapted to participants
Interventions/Control_2
No Contact Needle Techniques
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
Selection Criteria
We will target those who meet all of the following criteria.
1.Women aged between 40 and 59
2.Those who can obtain written consent for participation in this study
3.Volunteers who have applied to the research subject recruitment institution and are aware of continuous poor health
[Reason for setting selection criteria]
We selected middle-aged women who often complain of discomfort as the target for contact acupuncture. Also, since this study targets healthy people, we set such criteria.
Key exclusion criteria
Individuals with metal allergies
Individuals with skin diseases (including atopic dermatitis)
Individuals with large scars or bruises on their cheeks
Individuals who cannot apply medical gel to their face
Individuals with a history of smoking
Individuals with acne covering the entire face
Individuals who are currently pregnant, breastfeeding, or may be pregnant
Individuals with serious illnesses
Individuals with oral diseases (tongue, periodontal disease)
Individuals with a BMI under 18 or over 28
Individuals with tongue diseases
Individuals with hypertension, diabetes, dyslipidemia, or malignant tumors
Individuals who have undergone surgery within the last year
Individuals planning to get excessive sun exposure from two weeks before the first visit to the measurement test until its completion
Individuals currently undergoing acupuncture treatment
Others whom the research representative or test conductor deems inappropriate for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | OGAWA |
| Middle name | |
| Last name | KEIKO |
Organization
HIROSHIMA UNIVERSITY HOSPITAL
Division name
the Traditional Chinese Medicine Clinic
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
0822571921
okeiko22@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Kawahara |
Organization
HIROSHIMA UNIVERSITY HOSPITAL
Division name
the Traditional Chinese Medicine Clinic
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
0822571921
Homepage URL
abcd@hiroshima-u.ac.jp
Sponsor or person
Institute
HIROSHIMA university
Institute
Department
Personal name
Funding Source
Organization
SHISEIDO
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
Tel
0822571947
iryo-sinsa@office.hiroshima-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
| 2024 | Year | 06 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061938
