UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014000 |
|---|---|
| Receipt number | R000016307 |
| Scientific Title | Verifying the control effects of glucose absorption through the comparison of SekirenB2 with a placebo in double blind cross over comparative study. |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2017/09/08 16:10:25 |
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Basic information
Public title
Verifying the control effects of glucose absorption through the comparison of SekirenB2 with a placebo in double blind cross over comparative study.
Acronym
PRT-AD-MF-OGTT-SEKIREN-01-01
Scientific Title
Verifying the control effects of glucose absorption through the comparison of SekirenB2 with a placebo in double blind cross over comparative study.
Scientific Title:Acronym
PRT-AD-MF-OGTT-SEKIREN-01-01
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
SekirenB2(Adaptgen Pharmaceutial Co. Ltd.,) is test food of this clinical trial.
When we used test food that was made from SekirenB2 and LB-Scr(Laboag Co. Ltd.,) for diabetic in other clinical trial, we could confirm validity of the test food clearly.
And Echevaria grauca is raw material of SekirenB2 and functional foods material, which we can expect to control absorption of glucose in a small intestine and rising of blood glucose level.
That's why we use SekirenB2 and do carbohydrate tolerance test in this clinical trial.
We check rise inhibiting effect of glucose level by SekirenB2 of functional-foods that has safety and hasn't side effect.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We decide the value in front of test food ingestion start is standard and it is 0 hour.
We check the amount of change of the blood glucose level after ingesting test food and measure the level in 0.5, 1, 1.5, 2, 2.5, 3, 4 hours later.
Key secondary outcomes
We decide the value in front of test food ingestion start is standard and it is 0 hour.
We check the amount of change of theblood test item and the urinalysis item 4 hours later.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
SekirenB2
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)A person who is Japanese and between 20 and 65 years old at the time of informed consent.(Sex is not asked)
2)A person who has blood pressure and body temperature of the following value at this clinical trial and the screening.
Blood pressure:
Systolic Less than 140mmHg
Diastolic Less than 90mmHg
Body temperature: 35.5-37.0 degrees
3)A person whose HbA1c is applied to following either value.
a)HbA1c:6.4% or less
b)HbA1c:6.5% or more and less than 7.0%
4)A person must be received to explanation about the test food,objective of clinical test and side effects by clinical research investigator or sub investigator.
And the person who understood explanation well,agreed with written informed consent and desired participation in the clinical trial.
5)A person who can quit smoking on the day of clinical trial.
6)A person who can obey management manner in implementation medical institutions.
7)A person who can do screening test within 60 days of this clinical trials implementation and was qualified by clinical research investigator or sub clinical research investigator.
Exclusion criteria.
Key exclusion criteria
1)A person who is suspected to have an impaired liver function on result of clinical laboratory test at the screening.
a) T-Bil 3.0 or more
b) GOT,GPT More than normalcy upper limit multiply 2.5(100 or more)
c) A1-P More than normalcy upper limit multiply 2.5
d) gamma-GTP More than normalcy upper limit multiply 1.5
e) LDH More than normalcy upper limit multiply 1.5
2)A person who has disease of gastrointestinal tract, kidney and the heart which have an influence on absorption, distribution, metabolism and the excretion.
3)A person who has surgical history of gastrointestinal tract site.
For example gastrectomy, stomach and intestines suture, intestinal tract resection and so on.
4)A person who has food allergy.
5)A person who has alcohol or drug dependence.
6)A person who treated diabetes within 3 months at the time of obtaining informed consent.
7)A person who participated in other clinical study of new drug or received medical treatment within 3 months at the time of obtaining informed consent.
8)A person who take other medicine from less than one week to start this clinical trial.
9)A person who has taken the whole blood bleeds or ingredient blood collecting (plasma or plaque component blood collecting) more than 200ml within 3 months at the time of obtaining informed consent or during the period between the time of obtaining informed consent and this clinical trial implementation.
10)A person who can't obey management manner or can't report about subjective symptoms during participation in clinical trials.
11)In addition a person who is identified as improper by the responsibility researcher or subresponsibility researcher.
12)A woman who is pregnant or breastfeeding.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigehiro Kure |
Organization
Sanbongi Clinic
Division name
Clinic Director
Zip code
Address
2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
TEL
0561-56-4532
shigehiro_kure@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Hayashi |
Organization
Medical Fusion Co.,Ltd.
Division name
Clinical Development Division
Zip code
Address
Nagoya Life Science Incubator,2-22-8,Chikusa,Chikusa-ku,Nagoya,Aichi,464-0858,Japan
TEL
052-745-3300
Homepage URL
info@m-fusion.co.jp
Sponsor or person
Institute
ADAPTGEN PHARMACEUTICAL CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
ADAPTGEN PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1,Medical institutions conduct clinical research
MEDOC Medical Dock&Clinic
2,CRO
Medical Fusion Co.,Ltd.
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
医療法人メドック健康クリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 26 | 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
| 2014 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 19 | Day |
Last modified on
| 2017 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016307
