UMIN-CTR Clinical Trial

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 Hiroshi Middle name Last name Kakuto
Organization	Ehime Prefectural Central Hospital
Division name	East Asian Traditional Medicine
Zip code	790-0024
Address	83 Kasuga-machi Matsuyama-shi Ehime-ken
TEL	089-947-1111
Email	c-hkakutou@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
Institute	Ehime Prefectural Central Hospital
Institute
Department

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	2022 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.31.2022 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	2021 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.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

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