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Prophylactic study for COVID-19 with Kampo medicines

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200150
Enrollment
6000
Registered
2020-10-14
Start date
2020-11-27
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Respiratory Tract Infections

Interventions

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

Sponsors

Namiki Takao
Lead Sponsor
The Japan Society for Oriental Medicine
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
The number of COVID-19 PCR positives with symptoms

Secondary

MeasureTime frame
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

Contacts

Public ContactTakao Namiki

Medical Mycology Research Center Chiba University

tnamiki@faculty.chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 24, 2026