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

JRCT ID: jRCTs031220483

Registered date:02/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 16/12/2022
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Take one bottle once a day after breakfast.

Outcome(s)

• Primary Outcome: Subjective symptom: Visual analogue scale of fatigue

Secondary Outcome

1. 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 maximum: Not applicable
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Tsuyoshi Takara
• Source(s) of Monetary Support: Sato Pharmaceutical Co., Ltd