Double-blind, placebo-controlled study to evaluate adjuvanticity effects of Pleurotus cornucopiae extracts.
- Conditions
- immunodepletion
- Registration Number
- JPRN-UMIN000015208
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1.Subjects who are under medication for chronic ailments (especially diseases related to cancer, liver, kidney, heart, gastrointestinal tract, diabetes, hypertension, mental disorder etc) 2.Subjects with serious diseases or infections such as cerebrovascular, cardiac, liver, kidney, gastrointestinal tract or condition which need immediate reporting to the authorities 3.Subjects who are suspected of acute infection morbidity from diseases such as influenza 4.Subjects who undergo treatment for chronic inflammatory diseases autoimmune diseases or allergies etc 5.Subjects who receive vaccination 12 weeks before participating in this study or those who will get inoculated during this study period 6.Subjects who have a major surgical history such as gastrectomy, gastrointestinal suture surgery or intestinal resection etc 7.Subjects with frequent complaints of post-menopausal symptoms 8.Subjects with unusually high and/or low blood pressure, or with abnormal hematological data 9.Subjects with serious anemia 10.Subjects with a history of allergy to medicine and food (especially mushroom, soybean, wheat) 11.Subjects who regularly undertake medication which can affect the immune function (antibiotics, immunosuppressive drugs, anti-inflammatory drugs, anti-rheumatic drugs, antihistamines, anti-allergy drugs, lactic acid bacteria supplements etc.) Chinese herbal medicine, health food, supplements, extracts from (mushroom, seaweed, nucleic acids, yeast, lactic acid bacteria etc) 12.Heavy smokers, alcohol addicts or subjects with irregular lifestyle 13.Subjects who donate either 400ml whole blood within 12 weeks or plasma, platelets within 4 weeks or blood component within 2 weeks prior to this study 14.Subjects who are pregnant or under lactation or ones who would expect to be pregnant during the study 15.Subjects who participate in other clinical trials within the last one month prior to the current clinical trial 16.Subjects who are ineligible due to physician's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method atural killer cell activity
- Secondary Outcome Measures
Name Time Method Blood cortisol, IL-12, MIF, serum neopterin, blood pressure, fasting blood glucose, HbA1c, VAS questionnaire