UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055352 |
|---|---|
| Receipt number | R000063215 |
| Scientific Title | Investigation of nutritional status improvement by direct moxibustion |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2024/11/29 17:17:23 |
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Basic information
Public title
Investigation of nutritional status improvement by direct moxibustion
Acronym
D-MOX
Scientific Title
Investigation of nutritional status improvement by direct moxibustion
Scientific Title:Acronym
Investigation of nutritional status improvement by direct moxibustion
Region
| Japan |
Condition
Condition
the elderly
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether direct moxibustion is useful for nutritional status, immune function and activity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CONUT score
Key secondary outcomes
Weight, visceral fat, NK cell function, PS (Performance status)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Moxibustion treatment on ST36 for a total of 5 days every week for 12 weeks for patients over 65 years old.
Interventions/Control_2
None
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those that satisfy all of the following.
Inpatients aged 65 or older.
Having a diagnosis by a Kampo (Japanese herbal medicine) specialist that moxibustion treatment is suitable.
Key exclusion criteria
Any of the following.
Those who have taken new drugs within the last two weeks.
Patients with a history of hypersensitivity to thermal stimuli.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Ogawa |
Organization
Hiroshima University
Division name
Hospital Kampo Medical Center
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-1921
okeiko@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Ogawa |
Organization
Hiroshima University
Division name
Hospital Kampo Medical Center
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku,Hiroshima
TEL
082-257-1921
Homepage URL
okeiko@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku,Hiroshima
Tel
082-257-1551
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 | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was approved by the Kanazawa University Medical Ethics Review Committee on May 20, 2019, and the study was initiated. Later, due to a change in the principal investigator, the primary institution was changed to Hiroshima University, and the study was approved by the Hiroshima University Epidemiology Research Ethics Review Committee on February 21, 2022. Since the same research was taken over, the date of approval by the Kanazawa University Medical Ethics Review Committee, etc. are listed as UMIN information.
The date of protocol finalization at Hiroshima University is February 21, 2022, the date of approval by the Ethics Committee is December 22, 2021, and the date of (planned) start of registration and incorporation is February 21, 2022.
Management information
Registered date
| 2024 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063215
