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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040341
Receipt No. R000046023
Scientific Title Immunological efficacy of Qing Fei Pai Du Tang for COVID-19: an open-label, single-arm trial
Date of disclosure of the study information 2020/05/09
Last modified on 2020/05/17

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Basic information
Public title Immunological efficacy of Qing Fei Pai Du Tang for COVID-19
Acronym COVID-19/Qing Fei Pai Du Tang
Scientific Title Immunological efficacy of Qing Fei Pai Du Tang for COVID-19: an open-label, single-arm trial
Scientific Title:Acronym COVID-19/Qing Fei Pai Du Tang
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. The Qing Fei Pai Du Tang (QFPDT) is a Chinese multi-herbal formula newly developed and optimized specifically for patients with COVID-19. Recent clinical trials in China have demonstrated that the QFPDT successfully alleviates COVID-19 symptoms in a large number of mild to critical cases. 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 low-dose administration of QFPDT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma cytokine levels after administration of Qing Fei Pai Du Tang for 3 days
Key secondary outcomes Hematology and blood biochemistry after administration of Qing Fei Pai Du Tang for 3 days

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 We reduce the dose of each herb to 1/30 to explore the feasibility of prophylactic use. The QFPDT decoction is prepared by boiling the mixed herbs in 600 ml of water for 1 h and divided into six aliquots. The subjects are instructed to take the aliquot of the decoction orally 40 min after each breakfast and dinner for 3 days.
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
Email 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
Email jimukyoku@takanawa-clinic.com

Sponsor
Institute Administration Department, Takanawa Clinic
Institute
Department

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
Email 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 09 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 No longer recruiting
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 09 Day
Last follow-up date
2020 Year 05 Month 16 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 08 Day
Last modified on
2020 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046023

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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