Protocol summary
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Study aim
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Assessing the effect of hot foot bath on controlling the symptoms of hospitalized patients with COVID-19 and accelerating the healing process
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Design
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Randomized controlled clinical trial
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Settings and conduct
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Sixty hospitalized patients with a positive nasopharyngeal PCR test or suspected chest CT or chest X ray are randomly located in one of two groups of warm-water foot bath or control groups. Patients in the intervention group, in addition to the usual treatments, receive foot bath (warm water at 42 C for 20 minutes and then kept warm for 5 minutes) once a day for 7 days. The consequences of the study, including laboratory results, clinical signs, and chest CT scans, are measured at the time of admission and during the study until the end of day 7.
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Participants/Inclusion and exclusion criteria
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Patients enter the study with a positive nasopharyngeal RT-PCR test or positive chest CT scan or chest X ray. Patients cannot enter the study if they are intubated or hospitalized in the ICU, pregnancy and lactation, treatment with corticosteroids or immunosuppressive drugs, or the use of herbal medicines or other traditional and complementary medicine methods.
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Intervention groups
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Intervention group: They receive both usual treatments and foot bath (warm water at 42 C for 20 minutes and then kept warm for 5 minutes once a day for 7 days). Control group: They receive only They receive based on classical medicine.
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Main outcome variables
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Laboratory results (number of lymphocytes, CRP), clinical symptoms (fever, cough, myalgia, shortness of breath, chills), chest CT scan and anxiety
General information
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Reason for update
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adding (hot foot bath) to Persian title
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180923041093N5
Registration date:
2020-04-10, 1399/01/22
Registration timing:
prospective
Last update:
2020-04-21, 1399/02/02
Update count:
1
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Registration date
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2020-04-10, 1399/01/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-15, 1399/01/27
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Expected recruitment end date
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2020-05-16, 1399/02/27
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of hot foot-bath on controlling the symptoms of hospitalized patients with COVID-19 and accelerating the recovery process
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Public title
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Evaluation the efficacy of hot foot-bath on COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Conscious satisfaction
Positive naso-pharyngeal RT-PCR test or chest CT scan or chest X ray
Exclusion criteria:
Intubated patients or those admitted in ICU
Pregnancy or lactation
Patients treated with corticosteroids or immunosuppressive drugs
Use herbal medicines or other traditional and complementary medicine methods
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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By random blocking method with 4 blocks and using Random Allocation Software
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-05, 1399/01/17
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1399.029
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Temperature
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Timepoint
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Daily
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Method of measurement
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Thermometer
2
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Description
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Cough
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Timepoint
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Daily
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Method of measurement
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Fisman scale
3
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Description
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Respiratory rate
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Timepoint
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Daily
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Method of measurement
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Counting the number of breaths per minute
4
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Description
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Weakness
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Timepoint
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Daily
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Method of measurement
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Visual analog scale
5
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Description
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Muscular pain
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Timepoint
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Daily
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Method of measurement
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Visual analog scale
6
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Description
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C Reactive Protein (CRP)
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Timepoint
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Daily
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Method of measurement
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Blood test
7
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Description
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Lymphocyte count
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Timepoint
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Daily
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Method of measurement
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Blood test
8
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Description
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O2 Saturation percentage (SpO2)
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Timepoint
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Daily
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Method of measurement
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Pulse oximetery
9
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Description
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Anxiety
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Timepoint
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Daily
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Method of measurement
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Beck questionnare
10
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Description
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Chest X Ray
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Timepoint
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Daily
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Method of measurement
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Analysis of radiography
Secondary outcomes
1
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Description
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Number of admission days
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Timepoint
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Daily
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Method of measurement
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Counting admission days
2
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Description
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Mortality
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Timepoint
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Daily
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Method of measurement
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The ratio of death to total patients in each group
Intervention groups
1
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Description
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Intervention group: They receive both usual treatments and foot bath (warm water at 42 C for 20 minutes and then kept warm for 5 minutes once a day for 7 days).
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Category
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Treatment - Other
2
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Description
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Control group: They receive only usual treatments based on classical medicine.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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After completion of the study, information on the main outcome will be shared
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When the data will become available and for how long
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6 months after the publication of the article
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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Data and results will be available to all researchers for corona research.
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From where data/document is obtainable
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Email to mokaberi@sbmu.ac.ir
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What processes are involved for a request to access data/document
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The data will be provided to the applicant within one month after reviewing and confirming the request.
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Comments
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