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

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 - HKCOV

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041200072

Enrollment

100

Registered

2020-12-10

Start date

2020-12-10

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

COVID-19

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
The ratio of worsening within 10days after test drug administration	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactKeiko Ogawa

Hiroshima University hospital

okeiko@med.kanazawa-u.ac.jp+81-82-257-1921

Outcome results

None listed

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