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Safety confirmation test by intake of food containing plant extract

Safety confirmation test by intake of food containing plant extract - Safety confirmation test by intake of food containing plant extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036778
Enrollment
22
Registered
2020-05-16
Start date
2019-05-17
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

Healthy Japanese adult

Interventions

5 times amount overdose of plant extract-containing food for 4 weeks

Sponsors

Oneness support CO., LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy men and women aged 20 to 79 years old (2) BMI less than 30 (3) A person who has received a sufficient explanation of the purpose and contents of the study, has the ability to consent, voluntarily participates in a well-understood manner, and consents to the examination

Exclusion criteria

Exclusion criteria: People with a history of liver, kidney, digestive system, heart disease, respiration, endocrine, metabolism, nerve, consciousness disorder, diabetes, seizures, and other diseases that may affect the results of this test, or Person who has a history of surgery. Patients who have been hospitalized for treatment due to stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, brain contusion, head injury. Those who show abnormal liver and kidney function test values. Person who has disease under treatment now. Person with food and drug allergy. Person with anemia symptom. Those who have experienced ill mood or worsened physical condition by blood collection in the past. Those who donated more than 200 mL from the month before the start of the test to the start of the test, or those who have plans for it during the test period. Those who do intense sports and those who are on a diet. Person who has excessive smoking habit. Those who have an irregular diet. Persons who regularly use health food (including antioxidants, supplements with blood flow improvement effect) for the purpose of improving brain function or forgetfulness. Those who are taking medicines (anti-psychotic, anxiety, depressants, Parkinson's disease, epilepsy, blood clotting drugs, etc.) that may affect this study. Persons who can not quit the intake of health food (including food for specified health and functional indication food) or designated quasi-drugs during the test period. Those who are taking medication (including OTC and prescription drugs) continuously. Those who have consumed too much alcohol or who can not drink alcohol from the day before the test until the day. persons who are pregnant or who are planning pregnancy or breastfeeding during the study period. Those who are participating in or planning to participate in other clinical trials at the beginning of this trial, within 4 weeks after the end of the trial. Others who are judged inappropriate by the investigator.

Design outcomes

Primary

MeasureTime frame
Physical hand and physical examination Hematology and blood biochemistry Urinalysis Journal

Countries

Japan

Contacts

Public ContactMegumi Takahashi

RYUSENDO CO., LTD. Development Office

m.takahashi@ryusendo.co.jp03-3985-8346

Outcome results

None listed

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