Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Plant extract Administration: Take two capsules per day (one capsule each after breakfast and dinner) with water *If you forget to take the test food, take it as
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects aged 20 or more and less than 65 at the agreement to participate in this trial 2. Subjects with eye and nose discomfort 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who are positive specific IgE test against Japanese red-cedar, cypress, house dust, or Dermatophagoides pteronyssinus at screening 5. Subjects who have relatively high score in the total score of JRQLQ at the point of screening 6. Among the healthy subjects and those with mild symptoms, more than half of the enrolled subjects will be selected from healthy subjects. a. Healthy subjects: 1. Subjects suffering or having suffered from allergic reactions in their eyes and nose 2. Subjects not using antiallergic drugs before and during the trial b. Subjects with mild symptoms: 1. Subjects suffering or having suffered from allergic reactions in their eyes and nose 2. Subjects who sometimes (not regularly) used antiallergic drugs before and during this trial * "Sometimes" means using a drug as needed. * "Regularly use" means using a drug at fixed intervals even if there are no symptoms.
Exclusion criteria
Exclusion criteria: Subjects who (are) 1.undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an implantable cardioverter defibrillator 3.currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver, kidney, or cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4.currently being treated with any kind of drug or herbal medicine (except for single use) 5.have acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, or nasal septum deviation 6.have undergone nasal surgery (coagulation necrosis, excision, etc.) in the past 7.with concomitant bronchial asthma 8.have a symptom or a history of a serious liver, cardiac, renal, gastrointestinal, respiratory, endocrine, or metabolic disease (except for appendicitis) 9.undergoing specific hyposensitization 10.currently taking an oral or nasal antihistamine or antiallergic medication 11.take lactobacillus preparation and/or supplements or yogurt in daily use 12.take foods with antiallergic effects such as sweet tea, memehana tea etc. in daily use 13.take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 14.currently taking medications (including herbal medicines) and supplements 15.have a past or current medical history of allergies to medicines and/or foods 16.have a risk of allergies to the test food 17.have been enrolled in other clinical trials within the last 3 months before the agreement to participate in this trial or plan to participate another trial during this trial 18.pregnant, breast-feeding, or planning to become pregnant 19.drink alcohol immoderately 20.smokers 21.have experienced sick or deteriorated health after blood sampling in the past 22.may change their lifestyles, such as long trips, during this trial 23.judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value and change from screening of each score of the Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ) at four and eight weeks after consumption (4w and 8w) 2. The measured value of each question item of JRQLQ at 4w and 8w 3. The measured value of the questionnaire based on practical guideline for the management of allergic rhinitis in Japan at 4w and 8w | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values and changes from screening of serum specific IgE levels (Japanese red-cedar, cypress, house dust, and Dermatophagoides pteronyssinus), eosinophils count in nasal discharge, and serum basophils counts and eosinophil cationic protein (ECP) levels at 4w and 8w 2. The swelling of nasal mucosa at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed