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Clinical Trials/jRCTs041200072
jRCTs041200072CompletedNot Applicable

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)

Not provided0 sites100 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Primary Endpoint
-
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Prevention Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
20age old over to No limit (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

-

The ratio of worsening within 10days after test drug administration

Secondary Outcomes

  • Blood test
  • Changes in Kampo findings
  • CT findings
  • Deterioration rate(28th day)
  • Examination of antibodies before and after administration(28 days later)
  • Comparison before and after(10-day observation period)

Investigators

Sponsor
Not provided

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