UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047194 |
|---|---|
| Receipt number | R000053768 |
| Scientific Title | Measurements of fatigue with human herpes virus extracted from saliva (2) |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/01/05 10:16:48 |
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Basic information
Public title
Measurements of fatigue with human herpes virus (2)
Acronym
Measurements of fatigue with human herpes virus (2)
Scientific Title
Measurements of fatigue with human herpes virus extracted from saliva (2)
Scientific Title:Acronym
Measurements of fatigue with HHV6 (2)
Region
| Japan |
Condition
Condition
Normal subjects and patients
Classification by specialty
| Anesthesiology | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the possibility that HHV-6 DNA values can be used as an indicator of fatigue in medical staffs, extracted HHV-6 DNA from the saliva during and after engagement in treatment of COVID-19 patients. Additionally, we investigated the relationship between clinical symptoms (including smell disorder) and HHV-6 DNA values in patients with COVID-19.
Basic objectives2
Others
Basic objectives -Others
We prospectively examined the relevance between the amount of HHV-6 DNA from saliva and the degree of fatigue.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The amount of HHV-6 DNA from saliva and the degree of symptoms including general fatigue.
Key secondary outcomes
Vital signs and clinical symptoms
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal adult subjects and patients
Key exclusion criteria
Minors
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Inomata |
Organization
Univ. of Tsukuba
Division name
Dept. of Anesthesiology
Zip code
3058575
Address
Tennoudai 1-1-1, Tsukuba, Ibaraki, 3058575
TEL
029-853-7884
inomatas9981@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Inomata |
Organization
Univ. of Tsukuba
Division name
Dept. of Anesthesiology
Zip code
3058575
Address
Tennoudai 1-1-1, Tsukuba, Ibaraki, 3058575
TEL
029-853-7884
Homepage URL
inomatas9981@yahoo.co.jp
Sponsor or person
Institute
Univ. of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Univ. of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinichi Inomata
Address
Tennoudai 1-1-1, Tsukuba, Ibaraki, 3058575
Tel
029-953-7884
inomatas9981@yahoo.co.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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We suspected that human herpes virus 6 (HHV6) is part of the etiology of exanthema subitum in infants, and that HHV6 stays in salivary gland cells as a latent infection.In addition, the involvement of HHV6 has been noted in the relationship of chronic fatigue syndrome.To explore the possibility that HHV6 DNA values can be used as an indicator of fatigue, extracted HHV6 DNA from the saliva before and after the fatigue.We prospectively examined the relevance between the amount of HHV6 DNA from saliva and the degree of fatigue.The study was approved by the ethics committee of University of Tsukuba Hospital. Informed consent was obtained from each subject.The degree of fatigue was measured using Visual Analog Scale from 0 to 100. HHV6 DNA was extracted from saliva.DNA in the saliva was collected with the ORAgene DNA kit. Reverse transcription polymerase chain reaction was performed with the 7500 Fast Real Time PCR system and the TagMan Fast Universal PCR Master mix.The data were analyzed with unpaired or paired Student's t tests.
Management information
Registered date
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053768
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