Skip to content

Safety evaluation

Safety confirmation studies of excessive intake of black vinegar and black ginger extract processed food in healthy adult men and women. - Safety confirmation studies of excessive intake of black vinegar and black ginger extract processed food in healthy adult men and women.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048508
Enrollment
11
Registered
2022-10-01
Start date
2022-07-29
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

Oral intake 10 tablets of the test product daily for 4 weeks

Sponsors

EP Mediate Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy adult men and women between the ages of 20 and 64

Exclusion criteria

Exclusion criteria: (1) Subjects who intake health food richly containing black vinegar and black ginger (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 data (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

Countries

Japan

Contacts

Public ContactKazuma Masaki

EP Mediate Co., Ltd. Trial Planning Section R&D Support Center Foods Department

masaki.kazuma026@eps.co.jp070-4579-2569

Outcome results

None listed

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