COVI-19 Sequelae
Conditions
Interventions
The subjects of the study were assigned to either the "5-ALA phosphate / SFC-containing capsule intake group" or the "placebo capsule intake group", and in each group, 3 capsules of the test food were
Sponsors
Nagashima Hirotaka
Imamura Kyoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Among the sequelae of COVID-19, patients who are at least tired and who meet all of the following selection criteria are targeted. 1) Those who have been diagnosed with a new coronavirus infection within 6 months before obtaining consent 2) Men and women aged 20 to 75 at the time of consent 3) Those who have a feeling of fatigue after COVID-19 infection with VAS of 40 mm or more at Day 0 4) Those who can use smart watches and smartphone applications 5) Those who have voluntarily consented to the document
Exclusion criteria
Exclusion criteria: 1) Those who are pregnant or breastfeeding. Those who do not agree to contraception during the period of participation in this study if the study subject or the research subject's partner may become pregnant. 2) Persons with liver dysfunction 3) Persons with severe anemia 4) Percutaneous arterial oxygen saturation (SpO2)of 94% or less 5) Persons with diseases that are not controlled by treatment with pharmaceuticals, etc. 6) Those who are taking or plan to take supplements other than test foods, foods containing Hypericum erectum, which may affect this clinical study. 7) Those who are currently participating in other intervention clinical studies, or those who have participated in other intervention clinical studies within 3 months before obtaining consent. 8) Persons who are allergic or hypersensitive to 5-ALA and the ingredients contained in this test food, or porphyrins, or who have been confirmed to be intolerant 9) Persons with photosensitivity, persons taking drugs known to cause photosensitivity 10) Persons who have been diagnosed with porphyria or their family members 11) Persons with a history of hemochromatosis or viral hepatitis 12) Those who are allergic to smart watch bands 13)Those who have been vaccinated with the new corona vaccine within 6 months before obtaining consent 14) Others who are judged by the principal investigator or the investigator to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events, illnesses, etc. and side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Transition and rate of change of VAS value of fatigue (2) Transition of answers to the Pittsburgh sleep questionnaire recorded in the electronic diary at the start and end of intake (3) Changes in the score of COVID-19 sequelae symptoms reported by the study subjects on Day 0 (4) Changes in scores recorded in the electronic diary after evaluating QOL with EQ5D5L (5) Transition and rate of change of activity, body battery, stress, and sleep analysis results acquired by smart watch (6) Changes in other observations and inspection items during the test period | — |
Contacts
Public ContactHirotaka Nagashima
Tokyo Center Clinic
Outcome results
None listed