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Cupping Therapy on Immune System in Post Covid -19

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05901337
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
14.8
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Cupping therapy with convential medical treatment
  • Drug: Convential medical treatment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
single
Primary Purpose:
Treatment
Official Title:
Influence of Cupping Therapy on Immune System in Post Covid- 19 Patients
Actual Study Start Date :
Mar 7, 2022
Actual Primary Completion Date :
Jun 21, 2022
Actual Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cupping therapy with Convential medical treatment

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

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 .

Outcome Measures

Primary Outcome Measures

  1. T-lymphocyte [3months]

    1- Lymphocyte subset were analyzed from fluorescence-labeled flow cytometry on a DxFLEX flow cytometry by Kenza 240 Tx

  2. Serum Cytokine [3months]

    Cytokine detection Kenza reagents were provided from a 240 TX bio lap diagnostic apparatus by microsphere flow immunofluorescence

  3. ImmunoglobulinA,M,G [3 months]

    Kenza 240 TX for detection of immunoglobulin

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 66 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of physical therapy Giza Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Marwa Mohamed, master, Physiotherapist at Shoubra general hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marwa Mohamed Abd ElZahr, Dr, Cairo University
ClinicalTrials.gov Identifier:
NCT05901337
Other Study ID Numbers:
  • No:P.T.REC/012/003554
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jun 13, 2023