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A verification study of safety evaluation of excessive the test food consumption in humans: an open-label trial

A verification study of safety evaluation of excessive the test food consumption in humans: an open-label trial - A verification study of safety evaluation of excessive the test food consumption in humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032857
Enrollment
10
Registered
2018-06-04
Start date
2018-06-05
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 subjects

Interventions

Duration: 4 weeks Test material: Processed food containing mixed extracts of Paris Polyphylla var. Yunnanensis (Franch.) Hand.-Mazz, Hedyotis diffusa Wild, and Scutellaria barbata D.DON Dose: 10 pac

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician

Exclusion criteria

Exclusion criteria: 1. A medical history of malignant tumor, heart failure or myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Subjects who are currently taking medications (including herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, or planning to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

MeasureTime frame
1. Physical examination 2. Urinalysis 3. Blood test 4. Subjective symptoms (the Likert scale) * Assess these at screening (before consumption) and at 4 weeks after consumption

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