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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026288
Receipt No. R000030196
Scientific Title Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans
Date of disclosure of the study information 2017/02/24
Last modified on 2018/09/10

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Basic information
Public title Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans
Acronym Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans

Scientific Title Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans
Scientific Title:Acronym Safety evaluation study on overdose of acacia bark extract (Acacia Polyphenol) in humans

Region
Japan

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

Objectives
Narrative objectives1 Acacia bark extract is overdosed by healthy adults and safety is evaluated
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Inquiry, physical examination, and medical examination by hematology, blood biochemistry, urinalysis
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 4-week continuous intake of acacia bark extract
Interventions/Control_2 4-week continuous intake of placebo
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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1) 20<=Age=<64 of healthy men and women
Key exclusion criteria (1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases
(2) Subjects who indicate disorder of heart and lung function
(3) Subjects who indicate abnormal parameter in liver or kidney function
(4) Subjects who had a gastrointestinal surgery
(5) Subjects with a disease under treatment now
(6) Subjects with drug or food allergy
(7) Subjects who play high intensity sports or are on a diet
(8) Subjects who are taking medication or functional foods which might affect the results of this study, such as medicine, quasi drug and health foods
(9) Subject who consume exscessive alcohol
(10) Smoker
(11) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(12) Subjects who is participating in the other study or plannning to participate during the study period
(13) Subjects who isdeemed unsuitable by the principal investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Miura
Organization Miura Clinic, Medical Corporation Kanonkai
Division name Internal Medicine
Zip code
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL 06-6135-5200
Email info@miura-cl.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Terashima
Organization Oneness support Co., Ltd.
Division name Clinical trial Division
Zip code
Address Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL 06-4801-8917
Homepage URL
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization mimozax Co., Ltd.
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

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 01 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 27 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 02 Month 24 Day
Last modified on
2018 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030196

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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