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Safety Confirmation Test by Long-term Consumption of Test Food

Safety Confirmation Test by Long-term Consumption of Test Food - Safety Confirmation Test by Long-term Consumption of Test Food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049370
Enrollment
20
Registered
2022-12-16
Start date
2022-11-17
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

None

Interventions

Tablets containing 600 mg of hydrous ethanol extract of plant seeds

Sponsors

Akasaka Family Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy and free from chronic physical disease. The applicant must be able to give consent to participate in the study in writing after having been fully informed of the purpose and content of the study and having the ability and understanding of the study. The applicant must be able to come to the hospital on the designated date and undergo the examination. Those who are deemed suitable by the investigator to participate in the study.

Exclusion criteria

Exclusion criteria: Those who are currently undergoing drug treatment for some disease. Patients with a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc. Patients with a history of co-morbidities or a history of gastrointestinal disorders. Patients with alcohol dependence or other psychiatric disorders Patients who have taken any medication for the purpose of treatment of disease in the past 1 month (except for abrupt administration of medication for headache, menstrual cramps, common cold, etc.). The specific hay fever symptoms include: Birch: alder, birch, cedar, Japanese cypress; Asteraceae: ragweed, mugwort; Poaceae: ragweed, mugwort; Poaceae: chamogaya, Japanese mugwort; and Poaceae: Japanese knotweed, Japanese millet. Persons who may develop allergic symptoms to any of the ingredients in the tested foods, or who may develop serious allergic symptoms to other foods or medicines. Persons with severe anemia Persons who have a smoking habit. Women: Pregnant, lactating, or planning to become pregnant during the study period. Those who may change their lifestyle during the study period (e.g., work at night, travel for long periods, etc.). Those who are currently, or within the past 3 months have been, or will be taking functional foods, health foods, or supplements containing the ingredients of the food under study. Those who have undergone medical treatment involving hospitalization within the past 6 months. Those who have participated in other clinical studies within one month of obtaining consent to participate in this study, or those who plan to participate in other clinical studies after obtaining consent to participate in this study. Other subjects who are judged by the investigator to be inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
Hematological tests Blood Biochemistry Urinalysis Height, weight, BMI Measurement of systolic and diastolic blood pressure and pulse rate Interview by physician

Countries

Japan

Contacts

Public ContactSadao Mori

MORINAGA & CO., LTD. R & D Center

s-mori-ab@morinaga.co.jp045-571-6140

Outcome results

None listed

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