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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041502
Receipt No. R000047381
Scientific Title Combined effect of acupuncture and acupressure on lowering blood pressure: a pilot study
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/21

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Basic information
Public title Combined effect of acupuncture and acupressure on lowering blood pressure: a pilot study
Acronym Acupuncture and acupressure for lowering blood pressure
Scientific Title Combined effect of acupuncture and acupressure on lowering blood pressure: a pilot study
Scientific Title:Acronym Acupuncture and acupressure for lowering blood pressure
Region
Japan

Condition
Condition Hypertension/High-normal blood pressure
Classification by specialty
Cardiology Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of combined therapy of acupuncture and acupresseure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Systolic and diastolic pressure
Home blood pressure (morning/evening, 3 days)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Acupuncture treatment (1 session/week, total 4 sessions)
Acupressure (everyday at participant's home, total 28 sessions)
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
35 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1 Those who are able to join in the first and last examination.
2 Those with systolic blood pressure (SBP) 130 mmHg or diastolic blood pressure (DBP) 85 mmHg.
3 Those who joined in the explanation session and gave written informed consent.
Key exclusion criteria 1 Those who have hypertension (SBP 140/ DBP 90) and who does not have the permission of doctor.
2 Those with secondary hypertension (diabetes mellitus, chronic kidney disease, endocrine disease etc).
3 Those with stage 2 hypertension (SBP 180 mmHg/DBP 110 mmHg).
4 Those with history of stroke or Myocardial infarction.
5 Pregnant women during this study period.
6 Those with metal allergies.
7 Those who are judged by the principal investigator to be unsuitable as a research subject.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kiyohide
Middle name
Last name Tomooka
Organization Juntendo University
Division name Department of Public Health, Faculty of Medicine
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1049
Email k-tomoka@juntendo.ac.jp

Public contact
Name of contact person
1st name Kiyohide
Middle name
Last name Tomooka
Organization Juntendo University
Division name Department of Public Health, Faculty of Medicine
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1049
Homepage URL
Email k-tomoka@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Juntendo Clinical Research and Trial Center
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel 03-3814-5672
Email kenkyu5858@juntendo.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
2020 Year 09 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
2020 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 21 Day
Last modified on
2020 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047381

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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