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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040031
Receipt No. R000045638
Scientific Title Investigation of nutritional status improvement by direct moxibustion
Date of disclosure of the study information 2020/05/01
Last modified on 2020/04/02

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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 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes CONUT score
Key secondary outcomes Weight, visceral fat, NK cell function, PS (Performance status)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 1. Those that satisfy all of the following.
2. Inpatients aged 65 or older.
3. Having a diagnosis by a Kampo (Japanese herbal medicine) specialist that moxibustion treatment is suitable.
Key exclusion criteria 1. Any of the following.
2. Those who have taken new drugs within the last two weeks.
3. 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-Ochiai
Organization Kanazawa University Hospital
Division name Department of Japanese-Traditional (Kampo) medicine
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa-city, Ishikawa
TEL 076-265-2918
Email okeiko@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Mie
Middle name
Last name Morikawa
Organization Kanazawa University Hospital
Division name Department of Japanese-Traditional (Kampo) medicine
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa-city, Ishikawa
TEL 076-265-2918
Homepage URL
Email mmorika33@gmail.com

Sponsor
Institute Department of Japanese-Traditional (Kampo) medicine Kanazawa University Hospital
Institute
Department

Funding Source
Organization The Japan Society of Acupuncture and Moxibustion
Sasakawa Health Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Aichi Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Independent Ethics Committee in Graduate School of Medical Sciences, Kanazawa University
Address 13-1 Takaramachi, Kanazawa-city, Ishikawa
Tel 076-265-2832
Email rinri@adm.kanazawa-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 金沢大学附属病院(石川県)/ Kanazawa University Hospital(Ishikawa prefecture)
医療法人社団芙蓉会 二ツ屋病院(石川県)/ Futatsuya Hospital(Ishikawa prefecture)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 30 Day
Date of IRB
2019 Year 05 Month 20 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information This study investigates the efficacy of direct moxibustion before treatment and 4,8,12th weeks after treatment by CONUT Score, body weight, visceral fat mass, NK cell function, and PS (Performance Status).

Management information
Registered date
2020 Year 04 Month 02 Day
Last modified on
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045638

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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