UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023023 |
|---|---|
| Receipt number | R000026537 |
| Scientific Title | Effects of Acanthopanax senticosus intake on the changes of spectral analysis of heart rate variation in dizzy athletes. |
| Date of disclosure of the study information | 2016/07/14 |
| Last modified on | 2017/01/04 10:18:16 |
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Basic information
Public title
Effects of Acanthopanax senticosus intake on the changes of spectral analysis of heart rate variation in dizzy athletes.
Acronym
Effects of Acanthopanax senticosus intake: For spectral analysis of heart rate variation in athletes.
Scientific Title
Effects of Acanthopanax senticosus intake on the changes of spectral analysis of heart rate variation in dizzy athletes.
Scientific Title:Acronym
Effects of Acanthopanax senticosus intake: For spectral analysis of heart rate variation in athletes.
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 athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eart rate variability
Blood pressure
Heart rate
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The person who belongs to Doshisha University.
2) Who belong to sports clubs.
3)Athletes who present with dizziness.
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
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
kishii@mail.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
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
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
| 2016 | Year | 07 | Month | 14 | 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
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 15 | 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
| 2016 | Year | 07 | Month | 05 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026537
