UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040031
Receipt number R000045638
Scientific Title Investigation of nutritional status improvement by direct moxibustion
Date of disclosure of the study information 2020/05/01
Last modified on 2023/03/30 11:00:50

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

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

Institute

Department

Personal name



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

Terminated

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

2023 Year 03 Month 30 Day



Link to view the page

Value
https://center6.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