UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046305 |
|---|---|
| Receipt number | R000052846 |
| Scientific Title | Randomized single-blind parallel group controlled trials on the effects of medical qigong for human body in short and medium term |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2023/05/24 20:04:57 |
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Basic information
Public title
Effects of medical qigong for human body in short and medium term
Acronym
Effects of medical qigong for human body in short and medium term
Scientific Title
Randomized single-blind parallel group controlled trials on the effects of medical qigong for human body in short and medium term
Scientific Title:Acronym
Randomized single-blind parallel group controlled trials on the effects of medical qigong for human body in short and medium term
Region
| Japan |
Condition
Condition
Healthy adult male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of medical qigong for human body
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma cortisol and Stress survey (57 items) formulated by the Ministry of Health, Labor and Welfare, 8 weeks after the start of this study
Key secondary outcomes
Natural killer cell activity
Adrenocorticotropic hormone
25-OHVD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Medical qigong once a week for 4 weeks
Interventions/Control_2
Placebo group. Subjects take the same position as the medical qigong group, but do not receive medical qigong.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects capable of standing and lying down for 20 minutes
2) With or without underlying disease
3) Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to consent, have well understood, volunteered to participate, and have signed the informed consent document
Key exclusion criteria
1)Subjects whose consent was withdrawn during the study
2)Subjects who have difficulty standing for 20 minutes or more
3) Subjects who are pregnant or breast-feeding, or planning to be pregnant during the test period
4) Subjects who are judged as unsuitable for the study by the investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Nishijima |
Organization
Ebisu Plastic Surgery / Beauty Clinic
Division name
Plastic surgery
Zip code
1500022
Address
1-4-15 Ebisu Minami, Shibuya-ku, Tokyo Ebisu Ginza Cross Building 4F
TEL
03-5725-1115
akio-nishijima@higherself.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Yamada |
Organization
eneral Incorporated Association Medical Healing Associatio
Division name
CEO
Zip code
150-0031
Address
23-17 Sakuragaoka-cho, Shibuya-ku, Tokyo City Court Sakuragaoka 408
TEL
03-6869-2667
Homepage URL
support@medicalhealing.or.jp
Sponsor or person
Institute
Ebisu Plastic Surgery / Beauty Clinic
Institute
Department
Personal name
Funding Source
Organization
Ebisu Plastic Surgery / Beauty Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Haneginomori eye clinic Ethics Committee
Address
4-26-4 Daita, Setagaya-ku, Tokyo
Tel
03-6265-8777
mail@hanegi-eye.com
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
| 2021 | Year | 12 | Month | 13 | 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
| 2021 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052846
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
