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The verification study for safety evaluation of test food overdose in human: an open-label trial

The verification study for safety evaluation of test food overdose in human: an open-label trial - The verification study for safety evaluation of test food overdose in human

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023668
Enrollment
32
Registered
2017-06-19
Start date
2015-10-14
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 adults

Interventions

Duration: 4 weeks Follow-up duration: 2 weeks Test material: &quot
Dose: Take five capsules, three times a day Administration: Take five capsules after each meal

Sponsors

ORTHOMEDICO, Inc.
Lead Sponsor
1. Seishin-kai Medical Association Inc, Takara Medical Clinic. 2. Evaluation Center of Health and Nutrition Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adults

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines and/or herbal medicines 4. Allergic to medicines or foods related to the test food of this trial 5. Pregnant, lactating, or planning to get pregnant during the trial period 6. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 7. Judged unsuitable for participating in this trial by physician

Design outcomes

Primary

MeasureTime frame
1. Body measuring 2. Physical examination 3. Internal medicine examination 4. Blood test 5. Urinalysis 6. Subjective symptom *1 Perform examinations and tests at 0 week and at 2 and 4 weeks after the ingestion and at follow-up period 2 weeks

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO, Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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