UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041502 |
|---|---|
| Receipt number | 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 | 2023/12/25 15:32:41 |
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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
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
k-tomoka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
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
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
