Cupping Therapy on Immune System in Post Covid -19

Covid-19 Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901337
• Other study ID #: No:P.T.REC/012/003554
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 1, 2023
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid-19 Patients

Intervention

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 .

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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