COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs031210123

Hirotaka Nagashima

nagashima_hirotaka@tc-clinic.jp

2021-05-31

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Long covid

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 consent2) Men and women aged 20 to 75 at the time of consent3) Those who have a feeling of fatigue after COVID-19 infection with VAS of 40 mm or more at Day 04) Those who can use smart watches and smartphone applications5) Those who have voluntarily consented to the document

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 dysfunction3) Persons with severe anemia4) Percutaneous arterial oxygen saturation (SpO2)of 94% or less5) 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 intolerant9) Persons with photosensitivity, persons taking drugs known to cause photosensitivity10) Persons who have been diagnosed with porphyria or their family members11) Persons with a history of hemochromatosis or viral hepatitis12) Those who are allergic to smart watch bands13)Those who have been vaccinated with the new corona vaccine within 6 months before obtainingconsent14) Others who are judged by the principal investigator or the investigator to be inappropriate for this study

2

Nagashima Hirotaka

20

75

Japan

Patients recovered from covid

N/A

40

Frequency of adverse events; illnesses; etc. and side effects

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 4, "treatment_name": "5-ala/sfc", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]