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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041241
Receipt No. R000047099
Scientific Title Safety confirmation test of overdose intake of Okra seed extract -open-label trial-
Date of disclosure of the study information 2020/09/01
Last modified on 2020/07/29

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Basic information
Public title Safety confirmation test of overdose intake of Okra seed extract
Acronym Safety confirmation test of overdose intake of Okra seed extract
Scientific Title Safety confirmation test of overdose intake of Okra seed extract -open-label trial-
Scientific Title:Acronym Safety confirmation test of overdose intake of Okra seed extract -open-label trial-
Region
Japan

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

Objectives
Narrative objectives1 To identify the safety of excessive the test foods to consume 5 times of normal daily intake for 4 weeks in healthy Japanese subjects
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body measurement, physical examination
Hematology test
Blood biochemistry test
Urinalysis
Doctor's questions
Assess these at screening (before intake), at 2 and 4 weeks after intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test foods for 4 consecutive weeks (15 capsules/ day)
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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1) Healthy adult males and females between 20 to 64 years
(2) BMI: less than 30 kg/m2
(3) Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing
Key exclusion criteria (1) Subjects who were diagnosed with liver disease, kidney disease, gastrointestinal disease, heart disease, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery
(2) Subjects who indicate abnormal parameter in liver or kidney function
(3) Subjects with a disease currently under treatment
(4) Subjects with anemia
(5) Subjects who detect abnormal values by blood test
(6) Subjects who determine ineligible by principal investigator
(7) Subjects with drug or food allergies
(8) Subjects who play high intensity sports and/or are on a diet
(9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods
(10) Subjects who are under treatment with medications (including OTC or prescribed medication)
(11) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement
(12) Subjects with smoking habit
(13) Subjects with irregular life patterns and lifestyle of reversal of day and night
(14) Subjects who have a habit of excessive eating and drinking
(15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(16) Subjects who is participating in the other study or planning to participate during the study period
(17) Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Miura
Organization Miura Clinic, Medical Corporation Kanonkai
Division name Internal Medicine
Zip code 530-0044
Address 9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
TEL 06-6135-5200
Email tterashima@miula.co.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Terashima
Organization Oneness support Co., Ltd.
Division name Clinical trial Division
Zip code 530-0044
Address 4F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
TEL 06-4801-8917
Homepage URL
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Oneness support Co., Ltd.
Institute
Department

Funding Source
Organization BHN 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 Miura Clinic, Medical Corporation Kanonkai IRB
Address 9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
Tel 06-6135-5200
Email mterashima@oneness-sup.co.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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 28 Day
Date of IRB
2020 Year 07 Month 24 Day
Anticipated trial start date
2020 Year 08 Month 17 Day
Last follow-up date
2020 Year 09 Month 25 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=R000047099

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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