Effect of Ingestion of Perilla Extract for 8 weeks on Pollinosis Caused by Japanese White Birch(Betula platyphylla var. japonica).: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000027295
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 32
Not provided
1.Subjects who received a diagnosis from a doctor for an allergic disease in the past year. 2.Subjects who are very heavy hay fever symptoms with pollinosis questionnaire. 3. Subjects such as acute rhinitis, sinusitis. 4.Subject who have a history of cancer of the digestive system or those who are currently treated for medication. 5.Subject who have digestive disorders. 6.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 7.Subjects with major surgical history relevant to the digestive system. 8.Subjects with unusually high, low blood pressure, abnormal hematological data, severe anemia. 9.Pre- or post-menopausal women complaining of obvious physical changes. 10.Subjects who are at risk of having allergic reactions to drugs or perilla frutescens or gelatin. 11.Subject who use medicines prescribed for medical institutions for treatment of birch pollen allergy. 12.Subject who regularly take over-the-counter medicine to alleviate seasonal allergy-like symptoms. 13.Subject who regularly take prescription drugs and over-the-counter medicine for the purpose of improving bowel movements. 14.Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 15.Subject who can not stop taking intake of health foods and supplements or shiso juice during the examination period. 16.Excess smokers and regulars alcohol addicts or subjects with eating disordered lifestyle. 17.Subjects who donated a predetermined amount of blood in a given period. 18.Pregnant or lactating women or women who expect to be pregnant during this study. 19.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 20.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS questionnaire assessed pollinosis, questionnaire assessed pollinosis, white birch pollen-specific IgE
- Secondary Outcome Measures
Name Time Method non-specific IgE, Eosinophil, TARC, questionnaire assessed defecation status, VAS questionnaire assessed defecation status, PSQ questionnaire