healthy person
Conditions
Interventions
Duration: 4 weeks Test food: Plant extract material Dosage and administration: 5 tablets of 20 mg/1 tablet of plant extract material at breakfast, lunch and dinner (15 tablets/day, 300 mg of plant e
Sponsors
Clinical Creative Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: Men and women who are between 20 and 65 years old (at the time of obtaining consent) and able to go to 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 and are not receiving any related treatment or any kind of drug therapy. Whether or not a person qualifies as an able-bodied person is based on the person's declaration at the start of the examination). 3) The applicant must be able to avoid eating, drinking, and excessive exercise during the examination period, and must be able to lead the same lifestyle (eating and exercise habits, sleep, etc.) as he/she did before the examination period. 4) Those who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a good understanding of the purpose and content of the study, and who have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of treatment for heart failure, myocardial infarction, etc. 2) Exclusion due to disease, etc. (those suffering from or undergoing treatment for atrial fibrillation, arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic disease, etc.) 3)Those whose physical measurements, physical examination values, and clinical examination values in the preliminary examination show values that are significantly out of the reference range. 4) Those who regularly use pharmaceuticals (including herbal medicines) or supplements 5) Those who have allergies (to pharmaceuticals or food related to the tested products). 6) Pregnant, lactating, or likely to become pregnant during the study period. 7) Who have participated or are currently participating in other clinical trials within one month. 8) Other subjects who are judged by the investigator to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation at 5 times the recommended intake of 300 mg plant extract material | — |
Countries
Japan
Contacts
Public ContactKazuhiro Ohno
Clinical Creative Co., Ltd. Pharmaceutical Development Division
Outcome results
None listed