UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041249
Receipt No. 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 (Ver. 1)

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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
Email 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
Email k.kimura@kansai.ac.jp

Sponsor
Institute Kansai University of Health Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047104