UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043307
Receipt number R000034431
Scientific Title Evaluation of safety of acupuncture and moxibustion therapy including Blood-letting Therapy
Date of disclosure of the study information 2021/02/15
Last modified on 2024/02/20 17:49:53

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Basic information

Public title

Evaluation of safety of acupuncture and moxibustion therapy including Blood-letting Therapy

Acronym

Safety of Blood-letting Therapy

Scientific Title

Evaluation of safety of acupuncture and moxibustion therapy including Blood-letting Therapy

Scientific Title:Acronym

Safety of Blood-letting Therapy

Region

Japan


Condition

Condition

Chronic health disorder

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We positively investigate adverse events related to acupuncture and moxibustion therapy including Blood-letting Therapy and evaluate the safety quantitatively and qualitatively

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Adverse event occurrence frequency per total treatment number

Key secondary outcomes

Average treatment frequency per patient and frequency of adverse event occurrence
Content of adverse event


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients treated at our hospital

Key exclusion criteria

Patient who had no offer to attend

Target sample size

30000


Research contact person

Name of lead principal investigator

1st name Motoko
Middle name
Last name Otsuka

Organization

Ehime Prefectural Central Hospital

Division name

Acupuncture and Moxibustion Care Unit,East Asian Traditional Medicine

Zip code

790-0024

Address

83 Kasuga-machi Matsuyama-shi Ehime-ken

TEL

089-947-1111

Email

c-motsuka@eph.pref.ehime.jp


Public contact

Name of contact person

1st name Motoko
Middle name
Last name Otsuka

Organization

Ehime Prefectural Central Hospital

Division name

Acupuncture and Moxibustion Care Unit,East Asian Traditional Medicine

Zip code

790-0024

Address

83 Kasuga-machi Matsuyama-shi Ehime-ken

TEL

089-947-1111

Homepage URL


Email

c-motsuka@eph.pref.ehime.jp


Sponsor or person

Institute

Ehime Prefectural Central Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Morinomiya University of Medical Sciences

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ehime Prefectural Central Hospital

Address

83 Kasuga-machi Matsuyama-shi Ehime-ken

Tel

089-947-1111

Email

c-motsuka@eph.pref.ehime.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 02 Month 15 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

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB

2017 Year 11 Month 13 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Research design
:Prpspective exploratory study

How to recruit the target
:All patients receiving acupuncture and moxibustion therapy including Shiraku Therapy at Ehime prefectural central hospital Acupuncture and Moxibustion Care Unit from Dec.1.2017 to Mar.31.2027

Measurement item
:The contents of treatment(acupuncture・moxibustion・moxa needle・Shiraku Therapy)of the patient,contents of the incident


Management information

Registered date

2021 Year 02 Month 12 Day

Last modified on

2024 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034431


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name