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New Modality for Post Covid Syndrome Patients

Primary Purpose

Post Covid Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser acupuncture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Covid Syndrome

Eligibility Criteria

30 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age will be ranged from 30 to 40 years
  • patients were diagnosed as covid 19 by polymerase chain reaction test using nasopharyngeal swap
  • patients will be negative polymerase chain reaction test (pcr) with symptoms of dyspnea and fatigue.
  • patients will be recruited after 2 weeks post the negative pcr
  • patients who want to participate and complete the study till the end

Exclusion Criteria:

  • patients with photosensitivity
  • pacemaker plantation pregnant women
  • BMI more than 30kg/m2 infection or inflammation at the site of acupuncture laser malignancy uncontrolled diabetes psychiatric disorders or mental retardation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    group(1)

    group(2)

    Arm Description

    40 post covid 19 patients will receive laser acupuncture

    40 post covid patients will receive placebo laser acupuncture in which laser will be off

    Outcomes

    Primary Outcome Measures

    change in the level of CD 3 T cells
    5ml of blood will be drawn and serum will be separated. cd3 level will be measured using BD FACS Canto flow cytometer
    change in the level of cd4 T cells
    cd4 will be measured using BD FACS Canto flow cytometer after blood sample will be separated
    change in level of interleukin 4
    BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
    change in level of interleukin 6
    BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
    change in lymphocyte count
    BD FACS Canto flow cytometer will be used
    change in level of dyspnea
    mMRC scale is a five point scale to detect degree of dyspnea while performing physical activity. it is ranged from 0-4

    Secondary Outcome Measures

    change in fatigability
    chalder fatigue scale is 11 items scale. people of 4 or more are considered meeting the criteria of fatigue

    Full Information

    First Posted
    March 7, 2022
    Last Updated
    March 7, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05271500
    Brief Title
    New Modality for Post Covid Syndrome Patients
    Official Title
    Effect of Laser Acupuncture on Immunological Response and Dyspnea in Post Covid Syndrome Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    July 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Coronavirus (19) is a pandemic that affects many countries allover the world. Many patients experienced symptoms as dyspnea and fatigue after their recovery from coronavirus . These symptoms appear to occur regardless the severity of the infection. In addition, many studies reported change in the inflammatory status and immunity in post covid patients. laser acupuncture is a painless noninvasive modality that is used in treating many diseases. laser acupuncture appear to have a role in relieving symptoms, altering inflammatory status and boosting immunity in post covid patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Covid Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group(1)
    Arm Type
    Active Comparator
    Arm Description
    40 post covid 19 patients will receive laser acupuncture
    Arm Title
    group(2)
    Arm Type
    Placebo Comparator
    Arm Description
    40 post covid patients will receive placebo laser acupuncture in which laser will be off
    Intervention Type
    Device
    Intervention Name(s)
    laser acupuncture
    Intervention Description
    gallium-aluminum arsenide diode laser with a continuous wave and a wavelength of 850nm will be used for laser acupuncture. it will be applied for three times per week for 12 weeks
    Primary Outcome Measure Information:
    Title
    change in the level of CD 3 T cells
    Description
    5ml of blood will be drawn and serum will be separated. cd3 level will be measured using BD FACS Canto flow cytometer
    Time Frame
    after 12 weeks of treatment
    Title
    change in the level of cd4 T cells
    Description
    cd4 will be measured using BD FACS Canto flow cytometer after blood sample will be separated
    Time Frame
    after 12 weeks of treatment
    Title
    change in level of interleukin 4
    Description
    BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
    Time Frame
    after 12 weeks of treatment
    Title
    change in level of interleukin 6
    Description
    BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
    Time Frame
    after 12 weeks of treatment
    Title
    change in lymphocyte count
    Description
    BD FACS Canto flow cytometer will be used
    Time Frame
    after 12 weeks of treatment
    Title
    change in level of dyspnea
    Description
    mMRC scale is a five point scale to detect degree of dyspnea while performing physical activity. it is ranged from 0-4
    Time Frame
    after 12 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    change in fatigability
    Description
    chalder fatigue scale is 11 items scale. people of 4 or more are considered meeting the criteria of fatigue
    Time Frame
    after 12 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age will be ranged from 30 to 40 years patients were diagnosed as covid 19 by polymerase chain reaction test using nasopharyngeal swap patients will be negative polymerase chain reaction test (pcr) with symptoms of dyspnea and fatigue. patients will be recruited after 2 weeks post the negative pcr patients who want to participate and complete the study till the end Exclusion Criteria: patients with photosensitivity pacemaker plantation pregnant women BMI more than 30kg/m2 infection or inflammation at the site of acupuncture laser malignancy uncontrolled diabetes psychiatric disorders or mental retardation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    salma alghitany, PHD degree
    Phone
    00201229723881
    Email
    fardreams@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    sandra girguis, PHD degree
    Phone
    00201221426663
    Email
    sandra_sweety@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    shawky fouad, PHD degree
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    sandra girguis, PHD degree
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    New Modality for Post Covid Syndrome Patients

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