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Safety evaluation

Safety confirmation studies of excessive intake of rush extract in healthy adult men and women. - Safety confirmation studies of excessive intake of rush extract in healthy adult men and women.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052066
Enrollment
20
Registered
2023-09-07
Start date
2023-09-08
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 adult

Interventions

5 grains of the test product daily oral intake for 4 weeks.

Sponsors

EP Mediate Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy adult men and women between the ages of 18 and 64 (2) Subject who fully understand the purpose and content of the study and agree to participate in the research of their own volition

Exclusion criteria

Exclusion criteria: (1) Subjects who constantly use health food richly containing involvement ingredient. (2) Subjects who are judged as unsuitable for this study by the principal investigator based on the results of clinical examination or cardiopulmonary abnormality. (3) Subjects who have possibilities for emerging allergy related to the study. (4) Subjects having a disease requiring regular medication or a history of serious (5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (6) Subjects who are engaged in day / night shift work, midnight work, or irregular life habits. (7) Subjects who have participated in other clinical studies (8) Subjects who intend to become pregnant or lactating (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects who are judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Laboratory test (Hematologic test, Blood biochemistry test, Urine analysis), Physical examination (Blood pressure/pulsation, Weight/body mass index) and Adverse event Evaluate at points of 2 weeks and 4 weeks of intake and 2 weeks after the end of intake period

Countries

Japan

Contacts

Public ContactRio Fujiwara

EP Mediate Co., Ltd. Foods Department, Trial Planning Section 1

fujiwara.rio605@eps.co.jp070-7079-8488

Outcome results

None listed

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