Prophylactic study for COVID-19 with Kampo medicines

JRCT ID: jRCTs031200150

Registered date:14/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 27/11/2020
• Target sample size: 6000
• Study type: Interventional
• Intervention(s): 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).

Outcome(s)

• Primary Outcome: The number of COVID-19 PCR positives with symptoms

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Namiki Takao
• Secondary Sponsor: The Japan Society for Oriental Medicine