Unique ID issued by UMIN | UMIN000009543 |
---|---|
Receipt number | R000010799 |
Scientific Title | Explorative trial of efficacy of the food which contains LB-Scr as the main ingredients for allergic disease.a randomized, placebo controlled, parallel-group trial |
Date of disclosure of the study information | 2012/12/14 |
Last modified on | 2017/09/08 16:07:53 |
Explorative trial of efficacy of the food which contains LB-Scr as the main ingredients for allergic disease.a randomized, placebo controlled, parallel-group trial
PRT-LB-MF-AR-LBSCR-01-01
Explorative trial of efficacy of the food which contains LB-Scr as the main ingredients for allergic disease.a randomized, placebo controlled, parallel-group trial
PRT-LB-MF-AR-LBSCR-01-01
Japan |
Allergic rhinitis (hay fever)
Allergic conjunctivitis
Atopic dermatitis
Bronchial asthma
Medicine in general | Clinical immunology | Chest surgery |
Ophthalmology | Dermatology | Oto-rhino-laryngology |
Others
NO
The efficacy of the food consisting of LB-Scr and ECM-E(cockscomb extract containing hyaluronic acid) for allergic disease are verified. These are evaluated for a placebo.
The value of Ige and IL-12 level are investigated as items of examination. These are measured 0 day, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days after the food intake start.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
The efficacy of the food consisting of LB-Scr and ECM-E(cockscomb extract containing hyaluronic acid) for allergic disease are verified. These are evaluated for a placebo.
The value of Ige and IL-12 level are investigated as items of examination. These are measured 0 day, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days after the food intake start.
A general blood test, biochemical examination, urinalysis, insulin hyaluronic acid, serotonin and changes of skin condition observed by Robo Skin Analyzer RSA 50 made by Inforward,inc and other usefulness and safeties such as side effects are verified.
(A general blood test, a biochemical examination, urinalysis, and skin condition)
First day, 28th day, 56th day, 84th days 112nd day, 140th day and 168th day after the first day of ingestion.
(Serotonin)
First day, 56th day, 112nd day and 168th day after the first day of ingestion.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Numbered container method
2
Diagnosis
Medicine | Food |
LB-Scr and ECM-E
Ingestion period:168 plus or minus
7day
Intake:1800mg/time-Time before a meal 3 times
The number of times of a visit to the hospital: First day,28th day, 56th day, 84th days 112th day and 168th day
Placebo
Ingestion period:168 plus or minus
7day
Intake:1800mg/time-Time before a meal 3 times
The number of times of a visit to the hospital: First day,28th day, 56th day, 84th days 112th day and 168th day
13 | years-old | <= |
65 | years-old | >= |
Male and Female
The subjects for the experiment must be apatient who meets all the following standards.
1)The patient who is Japanese and is between 13 and 45 years old at the time of Informed Consent (Sex is not asked).
2)The patient who is taking medical treatment as a visitor or wishes to take medical treatment as a visitor (Only visitors).
3)the patient who has been diagnosed with one or more chronic allergic disease of the following through a year or in a certain season and is receiving medical treatment every time when the patient get the allergic disease.
Allergic rhinitis (hay fever)
Allergic conjunctivitis
Atopic dermatitis
Bronchial asthma
4)The patient who is taking medicine for allergic disease or can be regarded as the person who get prescription by medical institution from its chart.
5) Patients who can get written informed consent before enrolling the study.
However, the consent from a legal representative person must be obtained if a subject is underage.
The patient who corresponds to either of the followings can't participate in this clinical study.
1)The patient who changed diabetic medicine in the observation term till the first day of ingestion
2)The patient who has a food allergy of mushrooms (fungi) and the patient who has a chronic food allergy
3)The patient who has a food allergy in chicken and a chicken egg or a chronic food allergy
4)The patient who has a tattoo.
5)The patient who has Mucopolysaccharidosis
6)The patient who has the past of myocardial infarction
7)The patient who has the past of a coronary-arterial-blood line reconstruction way (PCI or CABG)
8)The patient who merges unstable angina pectoris
9)The patient who has the past of cerebrovascular disorder (except for asymptomatic lacunar infarction)
10)The patient who has the past of heart failure
11)The patient who has critical liver disease
12)The patient who has critical renal disease
13)The woman who is pregnant or the woman who wishes to become pregnant during exam time.
14)The woman who is under breast-feeding
15)The patient who has participated in other clinical study or received medical treatment of new drug within 12 weeks before the ingestion start of test meal.
16)The patient who is taking medical treatment of psychiatric disorder or the patient who is judged by a doctor to need medical treatment of psychiatric disorder.
17)In addition, the person who identified as improper by the investigator or subinvestigators.
51
1st name | |
Middle name | |
Last name | Shigehiro Kure |
Sanbongi Clinic
Clinic Director
2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
0561-56-4532
shigehiro_kure@yahoo.co.jp
1st name | |
Middle name | |
Last name | Hiromichi Hayashi |
Medical Fusion Co.,Ltd.
Clinical Development Division
Nagoya Life Science Incubator,2-22-8,Chikusa,Chikusa-ku,Nagoya,Aichi,464-0858,Japan
052-745-3300
info@m-fusion.co.jp
LABOAG Co.,Ltd.
(Charge of clinical research)
(Clinical research personnel)
Masahiro Tanaka, Kazuya Nishimoto, Daisuke Hakkaku, Motoyuki Akita
LABOAG Co.,Ltd.
Profit organization
Japan
1,Medical institutions conduct clinical research
MEDOC Medical Dock&Clinic
2,CRO
Medical Fusion Co.,Ltd.
3,OEM
ADAPTGEN PHARMACEUTICAL CO.,LTD.
Shachihata Inc,.
Provision of "PC approval"management software and electronic seal
YES
JMA-IIA00105
JMACCT CTR
医療法人メドック健康クリニック(愛知県)
2012 | Year | 12 | Month | 14 | Day |
Unpublished
Completed
2012 | Year | 10 | Month | 18 | Day |
2013 | Year | 01 | Month | 15 | Day |
2013 | Year | 09 | Month | 26 | Day |
2013 | Year | 11 | Month | 30 | Day |
2013 | Year | 12 | Month | 09 | Day |
2014 | Year | 01 | Month | 20 | Day |
Chiyo foods Co.,Ltd.
Chiyo Nakata
URL : http://www.khaos.co.jp/
(Audit the implementation date)
IRB CRO:Medical institution
July 30 2013
CRO:IRB
July 31 2013
2012 | Year | 12 | Month | 13 | Day |
2017 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010799
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |