Study of the additional effect of Kampo medicine on common cold symptoms in COVID-19 patients

Study of the additional effect of Kampo medicine on conventional treatment for common cold symptoms in mild to moderate stage COVID-19 patients, A Multicenter Randomized Clinical Trial - IMJEDI study-R1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs021200020

Enrollment

160

Registered

2020-08-25

Start date

2021-02-22

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

coronavirus disease 2019 (COVID-19) infectious disease, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), coronavirus disease 2019 (COVID-19)

Interventions

In both groups, symptomatic treatment including antipyretic, antitussive, expectorant, antiemetic, and probiotic agents will be administered. In the conventional treatment group, no treatment will be

kakkonto, shosaikotokakikyosekko

Kampo medicine, kakkonto, shosaikotokakikyosekko

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Disease name: COVID-19 (2) Clinical stage: Mild to moderate Mild: Minor clinical symptoms and no abnormal findings on chest image Moderate: Fever, respiratory tract symptoms, pneumonia image(ground glass shadows and infiltrated shadows) is recognized on the image, but no abnormality in breathing or oxygenation (3)Have cold-like symptoms(Cough, sputum, malaise, shortness of breath, any of which is "NRS 2 points or more") (4) Age: 20 years old or older (at the time of registration) (5) Gender: Male, Female (6) Communicable in Japanese (7) Outpatient , Inpatient (8) Written informed consent from the individual to participate in the study

Exclusion criteria

Exclusion criteria: (1) Difficulty to obtain informed consent because of dementia, mental illness, and mental symptoms (2) Patients who are allergy to Kampo formulas and western medicine using in this study (3) Pregnant and lactating patients (4) Patients who may not be able to follow up (5) Patients participating in clinical trials or other intervention studies (6) Patients with hypokalemia or taking furosemide or taking steroids (7) Those who have judged that the doctor in charge is not suitable for this study

Design outcomes

Primary

Measure	Time frame
Number of days ro improve fever (< 37.0 degrees Celsius ), cough, general malaise, dyspnea, diarrhea, and vomitting.	—

Secondary

Measure	Time frame
Severity outcome from enrollment to day 14	—

Contacts

Public ContactShin Takayama

Tohoku University Hospital

takayama@med.tohoku.ac.jp+81-22-728-3036

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026