healthy adults
Conditions
Interventions
Take 20g of Argi-U Granule 3-4 times a day for 7 days consecutively
Sponsors
Kagoshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects must have signed an informed consent form at age 20 or older (2) Subjects must have voluntarily signed written informed consent to participate in the study And also, subjects who desire to only investigate the end point without taking Argi-U Granule after understanding purpose of this study (3) Subjects who can and plan to visit the hospital according to the study schedule
Exclusion criteria
Exclusion criteria: (1) Subjects who have participated in interventional studies within 16 weeks prior to signing the patient informed consent (2) Subjects who have history disease such as endocrine/metabolic disease, autoimmune disorder and immunodeficiency affects the secondary end point (3) Subjects with serious complications such as heart failure, lung diseases, kidney failure, liver failure and uncontrolled diabetes (4) Subjects with cancer or history of cancer (5) Subjects or breast-feeding women, women suspected of being pregnant and patients who do not consent to prevent conception by taking appropriate means with the assistance of their partners during the study period (6) Subjects considered unsuitable for participation in the study by the principal investigators or sub-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Efficacy: Change in walking speed as measured by 10 meter walk test from Day 0 to Day 7 (time and number of steps) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Safety: Adverse event (frequency and severity) Effect on Endocrine (To reveal the endocrine on behalf of growth hormone on Day 0,7,14,28) Effect on metabolism (To reveal the metabolism on behalf of lactic acid, pyruvic acid and blood gas analysis on Day 0,7,14,28) Effect on immunity (To reveal the immunity on behalf of cytokine and chemokine on Day 0,7,14,28) | — |
Countries
Japan
Contacts
Public ContactEiji Matsuura
Kagoshima University Hospital Department of Neurology
Outcome results
None listed