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
Phase 2
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCTs041200072
- Lead Sponsor
- Ogawa Keiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of worsening within 10days after test drug administration
- Secondary Outcome Measures
Name Time Method 1) Blood test<br>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.<br>2) Examination of antibodies before and after administration<br>Blood anti-SARS-CoV-2 antibody (IgG, IgM) level (quantitative analysis by ELISA) before and after administration (28 days later), COVID-19-specific antibody<br>3) Changes in Kampo findings (subjective symptoms, desired diagnosis (complexion color, etc.), tongue diagnosis (tongue color, tongue coating, shape))<br>4) CT findings when each local government and the doctor in charge deem it necessary<br>5) Deterioration rate on the 28th day<br>6) Comparison before and after 1) -5) above in the group who requested administration of the study drug after the 10-day observation period