Cupping Therapy on Immune System in Post Covid -19

NCT ID: NCT05901337

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2023-06-01

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.

Conditions

Covid-19 Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cupping therapy with Convential medical treatment

Cupping therapy with Convential medical treatment

Group Type: ACTIVE_COMPARATOR

Cupping therapy with convential medical treatment

Intervention Type: COMBINATION_PRODUCT

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 :

1. Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .

2. Vitamine C: The recommended dietary dose 200 mg/day vitamin c

3. Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .

Convential medical treatment

Intervention Type: DRUG

Group B participants received convential medical treatment for 8 weeks in the form of :

1. Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .

2. Vitamine C: The recommended dietary dose 200 mg/day vitamin C

3. Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .

Convential medical treatment

Convential medical treatment

Group Type: ACTIVE_COMPARATOR

Cupping therapy with convential medical treatment

Intervention Type: COMBINATION_PRODUCT

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 :

1. Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .

2. Vitamine C: The recommended dietary dose 200 mg/day vitamin c

3. Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .

Convential medical treatment

Intervention Type: DRUG

Group B participants received convential medical treatment for 8 weeks in the form of :

1. Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .

2. Vitamine C: The recommended dietary dose 200 mg/day vitamin C

3. Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .

Interventions

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 :

1. Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .

2. Vitamine C: The recommended dietary dose 200 mg/day vitamin c

3. Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .

Intervention Type: COMBINATION_PRODUCT

Convential medical treatment

Group B participants received convential medical treatment for 8 weeks in the form of :

1. Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day for adults 70 and younger .

2. Vitamine C: The recommended dietary dose 200 mg/day vitamin C

3. Anticoagulation drugs ("blood thinners")Doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours .

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mohamed Abd ElZahr

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Mohamed, master

Role: PRINCIPAL_INVESTIGATOR

Physiotherapist at Shoubra general hospital

Locations

Faculty of physical therapy

Giza, , Egypt

Countries

Egypt

Other Identifiers

No:P.T.REC/012/003554

Identifier Type: -

Identifier Source: org_study_id