Skip to content

Double-blind, placebo-controlled study to evaluate adjuvanticity effects of Pleurotus cornucopiae extracts.

Double-blind, placebo-controlled study to evaluate adjuvanticity effects of Pleurotus cornucopiae extracts. - Adjuvanticity effects of Pleurotus cornucopiae extracts.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015208
Enrollment
40
Registered
2014-09-19
Start date
2014-09-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immunodepletion

Interventions

Pleurotus cornucopiae extracts 80mL per day for 8 weeks Placebo 80 mL per day for 8 weeks

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who show low NK cell activity. 2. Subjects who agree to participate in the current study with written informed consent.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Natural killer cell activity

Secondary

MeasureTime frame
Blood cortisol, IL-12, MIF, serum neopterin, blood pressure, fasting blood glucose, HbA1c, VAS questionnaire

Countries

Japan

Contacts

Public ContactDir. Prof. Jun Nishihira, M.D.

Hokkaido Information University Health Information Science Center

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026