UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027251
Receipt No. R000031218
Scientific Title Effects of Acanthopanax senticosus intake on the changes of spectral analysis of heart rate variation in elderly people.
Date of disclosure of the study information 2017/05/20
Last modified on 2017/08/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of Acanthopanax senticosus intake on the changes of spectral analysis of heart rate variation in elderly people.
Acronym Effects of Acanthopanax senticosus intake: For spectral analysis of heart rate variation in elderly people.
Scientific Title Effects of Acanthopanax senticosus intake on the changes of spectral analysis of heart rate variation in elderly people.
Scientific Title:Acronym Effects of Acanthopanax senticosus intake: For spectral analysis of heart rate variation in elderly people.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to investigate autonomic nervous system effect of Acanthopanax senticosus intake on the changes of spectral analysis of heart rate variation in elderly people
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate variability
Blood pressure
Heart rate
Key secondary outcomes Sleep questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Test group
Oral intake of tablets with 1628.4mg Acanthopanax senticosus extract twice a day after breakfast and supper for 4 weeks.
Interventions/Control_2 Control group
Oral intake of tablets without Acanthopanax senticosus extract twice a day after breakfast and supper for 4 weeks.
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
65 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Healthy Japanese men and women ages from 65 to 85 years old.
Key exclusion criteria 1) hypertensive patient
2) cardiac patient
3) diabetic patient
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kojiro Ishii
Organization Doshisha University
Division name Faculty of Health & Sports Science
Zip code
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-6724
Email kishii@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kojiro Ishii
Organization Doshisha University
Division name Faculty of Health & Sports Science
Zip code
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-6724
Homepage URL
Email kishii@mail.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

Funding Source
Organization Sun Chlorella Corp.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 同志社大学スポーツ健康科学部(京都府)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 20 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 Completed
Date of protocol fixation
2017 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 05 Day
Last modified on
2017 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031218

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.