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
About this trial
This is an interventional treatment trial for Post Covid Syndrome
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
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
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
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New Modality for Post Covid Syndrome Patients
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