UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040407 |
|---|---|
| Receipt number | R000046108 |
| Scientific Title | Immunological efficacy of Jinhua Qinggan Granule for COVID-19: an open-label, single-arm trial |
| Date of disclosure of the study information | 2020/05/15 |
| Last modified on | 2021/09/11 05:24:17 |
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Basic information
Public title
Immunological efficacy of Jinhua Qinggan Granule for COVID-19
Acronym
COVID-19/Jinhua Qinggan Granule
Scientific Title
Immunological efficacy of Jinhua Qinggan Granule for COVID-19: an open-label, single-arm trial
Scientific Title:Acronym
COVID-19/Jinhua Qinggan Granule
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A rapid increase in the numbers of patients with and deaths from COVID-19 is becoming a global threat to public health. One of the reasons for the current pandemic is that effective vaccine or specific drugs against COVID-19 remain unavailable. In China, traditional Chinese herbal medicine has been integrated into the official therapeutic protocols against COVID-19. Jinhua Qinggan Granule (JHQG) is a Chinese multi-herbal formula that is encouraged for the treatment of patients with COVID-19. However, the underlying pharmacological mechanism and the feasibility of prophylactic use in uninfected individuals remain unknown. We thus examine whether hematological and immunological parameters of healthy individuals are affected by the administration of JHQG Granule.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma cytokine levels 1 hour after the administration of JHQG
Key secondary outcomes
Hematology and blood biochemistry 1 hour after the administration of JHQG
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Duration: 1 hour
Dose: JHQG Granule 5 g
Number of doses: 1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
Current infectious, inflammatory, or immune-related diseases
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nakamura |
Organization
Institute for Quantitative Biosciences, The University of Tokyo
Division name
Laboratory of Molecular and Genetic Information
Zip code
113-0032
Address
1-1-1, Yayoi, Bunkyo-ku, Tokyo
TEL
03-5841-7834
nakamurachibiko@gmail.com
Public contact
Name of contact person
| 1st name | Tomoka |
| Middle name | |
| Last name | Ebisui |
Organization
Takanawa Clinic
Division name
Administration Department
Zip code
140-0001
Address
1-22-17, Kitashinagawa, Shinagawa-ku, Tokyo
TEL
03-6433-3165
Homepage URL
jimukyoku@takanawa-clinic.com
Sponsor or person
Institute
Administration Department, Takanawa Clinic
Institute
Department
Personal name
Funding Source
Organization
Administration Department, Takanawa Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Takanawa Clinic
Address
1-22-17, Kitashinagawa, Shinagawa-ku, Tokyo
Tel
03-6712-9747
support@idou-medical.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
高輪クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 14 | Day |
Last modified on
| 2021 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046108
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
