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Randomized controlled trial of prevention for COVID-19 with Kampo medicines (IMJEDI-P1 Study)

Prophylactic study for COVID-19 with Kampo medicines

Namiki Takao

Chiba University Hospital

1-8-1 Inohana Chuo-ku Chiba-city

tnamiki@faculty.chiba-u.jp

Namiki Takao

Medical Mycology Research Center Chiba University

1-8-1 Inohana Chuo-ku Chiba-city Chiba

+81-43-222-7171

tnamiki@faculty.chiba-u.jp

Recruiting

Oct. 14, 2020

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

prevention purpose

1) Age from 20 to 75 years old (at the time of registration)
2) Asymptomatic and body temperature below 37.0 degrees Celsius (at the time of registration)
3) Capable of eating orally

1)Previous upper respiratory inflammation due to viral infection (including suspected COVID-19)
2)Taking immunosuppressants
3)Allergic to any Kampo medicines
4)History of hypokalaemia, severe hypertension, severe liver dysfunction, and interstitial pneumonia
5)Regularly taking other Kampo medicines
6)Pregnant or possibly pregnant
7)Participating in other research
8)Judged to be unsuitable for this study by the doctor in charge

Both

COVID-19

Participants are randomly divided into two groups, a herbal medicine group, and a placebo group. Participants in each group continue to take 9 tablets twice a day orally before or between meals for 8 weeks (56 days).

Respiratory Tract Infections

Oral administration

065

The number of COVID-19 PCR positives with symptoms

1. The period from infection to onset
2. The period from the appearance of symptoms to the disappearance of PCR positive
3. Number of days until the appearance of symptoms or improvement of symptoms
4. Severe stage: Presence of hospitalization with oxygen inhalation
5. Shock stage: ICU management required for mechanical ventilation, shock vitals, or organ failure other than lungs

+81-43-226-2616

Aug. 19, 2020

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