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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 12 September 2017
Main ID:  JPRN-UMIN000009543
Date of registration: 14/12/2012
Prospective Registration: Yes
Primary sponsor: LABOAG Co.,Ltd. (Charge of clinical research) (Clinical research personnel) Masahiro Tanaka, Kazuya Nishimoto, Daisuke Hakkaku, Motoyuki Akita
Public 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
Scientific title:
Date of first enrolment: 2013/01/15
Target sample size: 51
Recruitment status: Completed
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010799
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Shigehiro Kure   
Address:  2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan Japan
Telephone: 0561-56-4532
Email: shigehiro_kure@yahoo.co.jp
Affiliation:  Sanbongi Clinic Clinic Director
Name: Hiromichi Hayashi   
Address:  Nagoya Life Science Incubator,2-22-8,Chikusa,Chikusa-ku,Nagoya,Aichi,464-0858,Japan Japan
Telephone: 052-745-3300
Email: info@m-fusion.co.jp
Affiliation:  Medical Fusion Co.,Ltd. Clinical Development Division
Key inclusion & exclusion criteria
Inclusion criteria: 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.

Exclusion criteria: 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.


Age minimum: 13years-old
Age maximum: 65years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Allergic rhinitis (hay fever) Allergic conjunctivitis Atopic dermatitis Bronchial asthma
Intervention(s)
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
Primary Outcome(s)
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.
Secondary Outcome(s)
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.
Secondary ID(s)
JMA-IIA00105
Source(s) of Monetary Support
LABOAG Co.,Ltd.
Shachihata Inc,. Provision of "PC approval"management software and electronic seal
Secondary Sponsor(s)
1,Medical institutions conduct clinical research MEDOC Medical Dock&Clinic 2,CRO Medical Fusion Co.,Ltd. 3,OEM ADAPTGEN PHARMACEUTICAL CO.,LTD.
Results
Results available:
Date Posted:
URL:
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