Clinical trial NCT05901337: Cupping Therapy on Immune System in Post Covid -19
Official title: Influence of Cupping Therapy on Immune System in Post Covid- 19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19 Patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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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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.

Eligibility criteria: 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.

Primary outcomes:
measure: T-lymphocyte
timeFrame: 3months
measure: Serum Cytokine
timeFrame: 3months
measure: ImmunoglobulinA,M,G
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: Physiotherapist at Shoubra general hospital
name: Marwa Mohamed, master
role: PRINCIPAL_INVESTIGATOR
References: