COVID-19 Prevention of worsening of symptoms in asymptomatic to mild patients by combined use of kakkonto and hochuekkito: Exploratory open-label randomized controlled trial

JRCT ID: jRCTs041200072

Registered date:10/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 15/02/2021
• Target sample size: 100
• Study type: Interventional

Intervention(s)

group A: non-administration group,
group B: Hochuekkito 5g before breakfast and dinner 2 + kakkonto 2.5g before dinner 1
The subjects of the study will take it for a total of 28 days
Those in group B can take test drugs if they want

Outcome(s)

• Primary Outcome: The ratio of worsening within 10days after test drug administration

Secondary Outcome

1) Blood test
Evaluate blood count, high-sensitivity CRP, coagulation factor, NK cell and T cell related receptor expression level, specific antibody, inflammation markers IL-6, ferritin, PLA2, KL-6, LDH, etc.
2) Examination of antibodies before and after administration
Blood anti-SARS-CoV-2 antibody (IgG, IgM) level (quantitative analysis by ELISA) before and after administration (28 days later), COVID-19-specific antibody
3) Changes in Kampo findings (subjective symptoms, desired diagnosis (complexion color, etc.), tongue diagnosis (tongue color, tongue coating, shape))
4) CT findings when each local government and the doctor in charge deem it necessary
5) Deterioration rate on the 28th day
6) Comparison before and after 1) -5) above in the group who requested administration of the study drug after the 10-day observation period

Key inclusion & exclusion criteria

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

Include criteria

1) SARS-CoV-2 is positive in nucleic acid detection or antigen test.
2) 20years old or over
3) Asymptomatic or mild symptoms.

Exclude criteria

1) Administration of kampo medicine (Juzendaihoto,Ninjinyoueito, Hochuekkito, Seishoekkito, Rikkunshito, Shikunshito, Kihito, Kamikihito) within the last two weeks
2) Persons with a history of hypersensitivity to Hochuekkito or Kakkonto
3) Those who participated in other clinical intervention studies (studies) within 3 months before the start of study drug administration
4) A person who is judged by the principal investigator or the investigator to be inappropriate as a research subject.
5) Those who are pregnant, may be pregnant, or are breastfeeding

Related Information

• Primary Sponsor: Ogawa Keiko
• Source(s) of Monetary Support: tsumura