Cupping Therapy on Immune System in Post Covid -19

Influence of Cupping Therapy on Immune System in Post Covid- 19 Patients

Purpose of this study is to investigate

1. The effect of Dry cupping therapy on T-Lymphocyte in post covid-19 patients.
2. The effect of Dry cupping therapy on serum Cytokine in post covid-19 patients.
3. The effect of Dry cupping therapy on Immunoglobulin IgA.
4. The effect of Dry cupping therapy on Immunoglobulin IgM.

5. The effect of Dry cupping therapy on Immunoglobulin IgG. seventy six patients of both genders with deficiency in T-Lymphocyte number,,higher level of serum cytokine and lower immunoglobulin IgA,IgM,IgG after two weeks of recovery from covid-19 . Age range from Twenty one to Sixty six years old .They participated in the study and recruited from surveillance unit of Shobra general hospital .These patients recruited by phone and have been offered to participate in the programme.The patients were divided equally into two groups (A and B). Assessment was done before and after treatment. T-Lymphocyte, serum cytokine and immunoglobulin IgA, IgM and IgG were analyzed by kenza 240 TX from fluorescence-labeled flow cytometry. Disposable cupping therapy instrument was used in treatment of group (A) in addition to traditional medical treatment in the form of vitamin C, D and anticoagulant drugs. Traditional medical treatment only was used in treatment of group (B).The obtained results of this study will determine the significant improvement of participated two groups.

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Study Overview

• Status: Completed
• Conditions: Covid-19 Patients
• Intervention / Treatment: Combination product: Cupping therapy with convential medical treatment; Drug: Convential medical treatment

Detailed Description

Patient were selected randomly and distributed in two groups by computer generation. The sample size was calculated using the G*Power software (version 3.0.10). F-test MANOVA within and between interaction effects was selected. Considering a power of 0.80, an α level of 0.05 (2 tailed) and effect size of 0.39; two groups and response variables of five, a generated sample size of at least 38 participants per group was required and total sample size of 76 subjects.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients with body mass index(BMI) 25.0-29.9 kg/m2 recruited two weeks post recovary from covid-19 and have lower T-lymphocyte and elevated cytokine All patients were clinically and medically stable.All patients recruited by phone and have been offered to participate in the programme.All patients will sign the informed consent before joining the study. Age range from 21 to 66 years .Subjects will be divided equally into two groups A,B. Assessment will be done before and after treatment.

Exclusion Criteria:

Patients will be excluded if they have any of the following criteria:

1. History of acute or chronic infections
2. Hepatobiliary diseases
3. Hematological diseases
4. Urinary system diseases
5. Nutrition and metabolism diseases
6. Rheumatic diseases
7. Endocrine diseases
8. Circulatory system diseases
9. Muscle trauma
10. Hypertension Further, if they fulfilled any of the following testing criteria
11. Hepatitis C virus antibodies
12. Human immunodeficiency virus antibodies
13. Creatinine above 120 μmol/L
14. Creatine kinase above 500 U/L
15. Uric acid above 475 μmol/L, glucose above 7.0 mmol/L
16. C-reactive protein above 12.0 m.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cupping therapy with Convential medical treatment	Combination product: Cupping therapy with convential medical treatment; Device:Cupping therapy device Group A participants received Dry cupping therapy one session per week for 8 weeks with 6 days intervals between sessions and with cups applied to the skin for around 8 minutes. (In addition to convential medical treatment for 8 weeks in the form of : Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .; Vitamine C: The recommended dietary dose 200 mg/day vitamin c; Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .; Drug: Convential medical treatment; Group B participants received convential medical treatment for 8 weeks in the form of : Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .; Vitamine C: The recommended dietary dose 200 mg/day vitamin C; Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .
Active Comparator: Convential medical treatment	Combination product: Cupping therapy with convential medical treatment; Device:Cupping therapy device Group A participants received Dry cupping therapy one session per week for 8 weeks with 6 days intervals between sessions and with cups applied to the skin for around 8 minutes. (In addition to convential medical treatment for 8 weeks in the form of : Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .; Vitamine C: The recommended dietary dose 200 mg/day vitamin c; Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .; Drug: Convential medical treatment; Group B participants received convential medical treatment for 8 weeks in the form of : Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .; Vitamine C: The recommended dietary dose 200 mg/day vitamin C; Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T-lymphocyte	1- Lymphocyte subset were analyzed from fluorescence-labeled flow cytometry on a DxFLEX flow cytometry by Kenza 240 Tx	3months
Serum Cytokine	Cytokine detection Kenza reagents were provided from a 240 TX bio lap diagnostic apparatus by microsphere flow immunofluorescence	3months
ImmunoglobulinA,M,G	Kenza 240 TX for detection of immunoglobulin	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Marwa Mohamed, master, Physiotherapist at Shoubra general hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): June 21, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 11, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Estimated): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: No:P.T.REC/012/003554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No