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Completed

NCT Number: NCT05901337

Cupping Therapy on Immune System in Post Covid -19

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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Key information

Conditions

COVID-19 Patients

Age range

21 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • History of acute or chronic infections
  • Hepatobiliary diseases
  • Hematological diseases
  • Urinary system diseases
  • Nutrition and metabolism diseases
  • Rheumatic diseases
  • Endocrine diseases
  • Circulatory system diseases
  • Muscle trauma
  • Hypertension Further, if they fulfilled any of the following testing criteria
  • Hepatitis C virus antibodies
  • Human immunodeficiency virus antibodies
  • Creatinine above 120 μmol/L
  • Creatine kinase above 500 U/L
  • Uric acid above 475 μmol/L, glucose above 7.0 mmol/L
  • C-reactive protein above 12.0 m.

Treatment and study plan

Cupping therapy with convential medical treatment

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 :

  • 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 .

Convential medical treatment

Drug

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 .

Primary outcomes

  1. T-lymphocyte

    Time frame: 3months

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

  2. Serum Cytokine

    Time frame: 3months

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

  3. ImmunoglobulinA,M,G

    Time frame: 3 months

    Kenza 240 TX for detection of immunoglobulin

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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