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Overdose safety test

Overdose safety study using rosemary material - Overdose safety study using rosemary material

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046475
Enrollment
22
Registered
2022-01-06
Start date
2022-01-06
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 person

Interventions

Duration:4 weeks Test food:Rosemary material Dosage and Administration:Take 5 rosemary capsules twice a day, after breakfast, lunch and dinner.

Sponsors

Clinical Creative Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age:Men and women between 20 and 65 years old (at the time of obtaining consent) who are able to visit the hospital. 2.Healthy subjects (Healthy subjects in this study are defined as those who do not have any serious organ disorder or specific disease, who are not receiving any related treatment, and who are not receiving any medication. Whether or not a person falls under the category of healthy person shall be based on the declaration of the person himself/herself at the start of the study.) 3.Must be able to consume the test food for 4 weeks 4.Those who do not plan to change their daily habits during the examination period. 5.Persons for whom written consent can be obtained 6.Those who do not meet the following exclusion criteria for study participants

Exclusion criteria

Exclusion criteria: 1.Those with a history of treatment for heart failure, myocardial infarction, etc. 2.Exclusion due to disease, etc. (those undergoing treatment for atrial fibrillation, arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases, etc.) 3.Those who meet the Japanese Society for Medical Checkup criteria D (medical care required). However, this does not apply to those who are judged by the physician to be within the normal error range. 4.Those who regularly use medicines (including herbal medicines)and supplements 5.Those with allergies (to pharmaceuticals and test product-related foods) 6.Pregnant, lactating, or likely to become pregnant during the study period 7.Those who have participated or are currently participating in other clinical trials within one month 8.Any other person who is judged by the principal investigator to be inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
Safety assessment of the recommended intake of 1000 mg rosemary material, which is five times the recommended intake of 200 mg rosemary material

Countries

Japan

Contacts

Public ContactKAZUHIRO OHNO

Clinical Creative Co., Ltd. Pharmaceutical Development Division

k-ohno@cli-creative.com09031166218

Outcome results

None listed

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