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

JRCT ID: jRCTs021200020

Registered date:25/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: coronavirus disease 2019 (COVID-19)
• Date of first enrollment: 22/02/2021
• Target sample size: 160
• Study type: Interventional

Intervention(s)

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 added.
In the additional Kampo treatment group, daily 7.5g of kakkonto and 7.5g of shosaikotokakikyosekko extract granule for ethical use (Tsumura & Co, Tokyo, Japan) before meal will be added for 14 days.

Outcome(s)

• Primary Outcome: Number of days ro improve fever (< 37.0 degrees Celsius ), cough, general malaise, dyspnea, diarrhea, and vomitting.
• Secondary Outcome: Severity outcome from enrollment to day 14

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takayama Takayama Shin
• Source(s) of Monetary Support: Tsumura &amp; Co.