UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043107
Receipt number R000048410
Scientific Title Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)
Date of disclosure of the study information 2021/01/23
Last modified on 2023/01/26 09:00:11

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Basic information

Public title

Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)

Acronym

Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)

Scientific Title

Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)

Scientific Title:Acronym

Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)

Region

Japan


Condition

Condition

Man and women

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examined the association of hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine).

Basic objectives2

Others

Basic objectives -Others

Internet survey, cross-sectional research, the association of hie disorder physical and oriental medicine state (Five Viscera and Constitution in Chinese Medicine).

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The contents of the survey were age, sex, hie disorder status, hie disorder physical of numerical rating scale(NRS), hie scale, Five Viscera Score and Constitution in Chinese Medicine Questionnaire (CCMQ).

Key secondary outcomes



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

18 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

the subjects were Japanese women and man living in Japan.

Key exclusion criteria

the study were age, those who did not fill in the survey items.

Target sample size

302


Research contact person

Name of lead principal investigator

1st name ryouta
Middle name
Last name tsuji

Organization

Morinomiya University of Medical Sciences

Division name

Department of acupuncture and moxibustion,Faculty of Health Sciences

Zip code

559-8611

Address

1-26-16, nankoukita suminoeku oosaka city, Osaka prefecture, 559-8611

TEL

+81-6-6616-6911

Email

tsuji@morinomiya-u.ac.jp


Public contact

Name of contact person

1st name hiroshi
Middle name
Last name kuge

Organization

Osaka Medical College Hospital

Division name

Department of Anesthesiology pain clinic

Zip code

569-8686

Address

2-7, daigakumachi Takatsuki city, Osaka prefecture, 569-8686

TEL

+81-90-1487-1151

Homepage URL


Email

sherry@kha.biglobe.ne.jp


Sponsor or person

Institute

Morinomiya University of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Morinomiya University of Medical Sciences

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

Morinomiya University of Medical Sciences

Address

1-26-16, nankoukita suminoeku oosaka city, Osaka prefecture, 559-8611

Tel

+81-6-6616-6911

Email

tsuji@morinomiya-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

2021 Year 01 Month 23 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

2020 Year 10 Month 01 Day

Date of IRB

2021 Year 01 Month 22 Day

Anticipated trial start date

2022 Year 12 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Internet survey, cross-sectional research


Management information

Registered date

2021 Year 01 Month 23 Day

Last modified on

2023 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048410


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name