NIPH Clinical Trials Search

JRCT ID: jRCTs031220483

Registered date:02/12/2022

Study to verify the effectiveness of SYS-055 administration in reducing fatigue

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNone
Date of first enrollment16/12/2022
Target sample size15
Countries of recruitment
Study typeInterventional
Intervention(s)Take one bottle once a day after breakfast.


Primary OutcomeSubjective symptom: Visual analogue scale of fatigue
Secondary Outcome1. Subjective symptoms: POMS2, Chalder's Fatigue Scale 2. Stress: blood cortisol, salivary cortisol, salivary amylase 3. Oxidative stress: blood d-ROMs, blood BAP, BAP/d-ROMs, urinary 8-OHdG 4. Immune function: NK cell activity 5. Autonomic nervous system function 6. Physical function: Physical Work Capacity test using ergometer 7. Psychological testing: Uchida-Kraepelin test

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria1. Japanese 2. Japanese male or female, 18 years of age or older 3. Subjects who are judged by the principal investigator to be safe to participate in the study based on the BDI-II results at the screening test
Exclude criteria1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects whose lifestyles are irregular (whose habits vary every day such as dietary habits, exercise habits, and sleeping habits) 5. Subjects who do not take 3 meals a day including breakfast 6. Subjects who have physical labor such as transportation of heavy objects 7. Subjects who are currently taking medications (including herbal medicines) and supplements 8. Subjects who habitually take excessive amounts of soft drinks containing caffeine (such as energy drinks) 9. Subjects who regularly take foods or medicines containing ingredients that may affect fatigue or stress 10. Subjects who are allergic to medications and/or the test-food-related products (particularly alcohol) 11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 12. Subjects who suffer from COVID-19 13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. Subjects who are judged as ineligible to participate in this study by the physician

Related Information


Public contact
Name Suzuki Naoko
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo, Japan Tokyo Japan 112-0002
Telephone +81-3-3813-5106
Affiliation ORTHOMEDICO Inc.
Scientific contact
Name Takara Tsuyoshi
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan. Tokyo Japan 141-0022
Telephone +81-3-5793-3623
Affiliation Medical Corporation Seishinkai, Takara clinic