UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041249 |
|---|---|
| Receipt number | R000047104 |
| Scientific Title | The mechanism and the effect of acupuncture on essential hypertension |
| Date of disclosure of the study information | 2020/07/30 |
| Last modified on | 2020/07/29 17:25:16 |
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Basic information
Public title
The mechanism and the effect of acupuncture on essential hypertension
Acronym
The mechanism and the effect of acupuncture on essential hypertension
Scientific Title
The mechanism and the effect of acupuncture on essential hypertension
Scientific Title:Acronym
The mechanism and the effect of acupuncture on essential hypertension
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of acupuncture on blood pressure and heart rate for essential hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Brood pressure
Key secondary outcomes
1.Heart rate
2.Heart rate variability
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture (One session, 15min)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
The patient group included patients with prehypertension (SBP 130-139mmHg or DBP 80-89mmHg or stage 1 hypertension (SBP 140-159mmHg or DB P90-99mmHg). The control group included eight age-matched men with normal BP.
Key exclusion criteria
The exclusion criteria were secondary hypertension; diabetes; a history of cerebrovascular or cardiovascular disease; kidney, liver, thyroid grand, or hemorrhagic disease; and infections disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kimura |
Organization
Kansai University of Health Sciences
Division name
Department of Health Sciences
Zip code
590-0482
Address
Wakaba 2-11-1, Kumatori, Osaka,Japan
TEL
0724-53-8251
k.kimura@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Kimura |
Organization
Kansai University of Health Sciences
Division name
Department of Health Sciences
Zip code
590-0482
Address
Wakaba 2-11-1, Kumatori, Osaka, Japan
TEL
0724-53-8251
Homepage URL
k.kimura@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
The Human Investigation Committee
Address
Wakaba 2-11-1, Kumatori, Osaka, Japan
Tel
0724-53-8251
k.kimura@kansai.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
関西医療大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 30 | 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
16
Results
The present study suggest that acupuncture may reduce the BP and HR of patients with mild hypertension ; the results of the heart rate variability (HRV)analysis suggest that basal cardiac sympathetic nerve activity(CSNA) is enhanced in patients with mild hypertension, which may be suppresses CSNA but also increases vagal nerve activity.
Results date posted
| 2020 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patient group included eight male patients(34.8years) with prehypertension or stage1hypertension. The control group included eight age matched men (34.6years) with normal BP.
Participant flow
Adverse events
No adverse events
Outcome measures
SBP and HF significantly decreased in the patient group during and after acupuncture compared with baseline values(p<0.05). SBP was significantly different between the two groups(p<0.05). HRV analysis showed that LF/HF was significantly reduced during acupuncture (p<0.05) and HF was significantly increased after acupuncture (p<0.05) in the patient group.
Plan to share IPD
No plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 20 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2020 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047104
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