Allergic rhinitis (hay fever) Allergic conjunctivitis Atopic dermatitis Bronchial asthma
Conditions
Interventions
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 112
Sponsors
LABOAG Co.,Ltd. (Charge of clinical research) (Clinical research personnel) Masahiro Tanaka, Kazuya Nishimoto, Daisuke Hakkaku, Motoyuki Akita
1,Medical institutions conduct clinical research MEDOC Medical Dock&
Clinic 2,CRO Medical Fusion Co.,Ltd. 3,OEM ADAPTGEN PHARMACEUTICAL CO.,LTD.
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactHiromichi Hayashi
Medical Fusion Co.,Ltd. Clinical Development Division
Outcome results
None listed