search
Back to results

Cupping Therapy on Immune System in Post Covid -19

Primary Purpose

Covid-19 Patients

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cupping therapy with convential medical treatment
Convential medical treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 Patients

Eligibility Criteria

21 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cupping therapy with Convential medical treatment

Convential medical treatment

Arm Description

Cupping therapy with Convential medical treatment

Convential medical treatment

Outcomes

Primary Outcome Measures

T-lymphocyte
1- Lymphocyte subset were analyzed from fluorescence-labeled flow cytometry on a DxFLEX flow cytometry by Kenza 240 Tx
Serum Cytokine
Cytokine detection Kenza reagents were provided from a 240 TX bio lap diagnostic apparatus by microsphere flow immunofluorescence
ImmunoglobulinA,M,G
Kenza 240 TX for detection of immunoglobulin

Secondary Outcome Measures

Full Information

First Posted
June 11, 2023
Last Updated
June 11, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05901337
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Purpose of this study is to investigate The effect of Dry cupping therapy on T-Lymphocyte in post covid-19 patients. The effect of Dry cupping therapy on serum Cytokine in post covid-19 patients. The effect of Dry cupping therapy on Immunoglobulin IgA. The effect of Dry cupping therapy on Immunoglobulin IgM. 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. .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
single
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cupping therapy with Convential medical treatment
Arm Type
Active Comparator
Arm Description
Cupping therapy with Convential medical treatment
Arm Title
Convential medical treatment
Arm Type
Active Comparator
Arm Description
Convential medical treatment
Intervention Type
Combination Product
Intervention Name(s)
Cupping therapy with convential medical treatment
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Convential medical treatment
Intervention Description
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 Outcome Measure Information:
Title
T-lymphocyte
Description
1- Lymphocyte subset were analyzed from fluorescence-labeled flow cytometry on a DxFLEX flow cytometry by Kenza 240 Tx
Time Frame
3months
Title
Serum Cytokine
Description
Cytokine detection Kenza reagents were provided from a 240 TX bio lap diagnostic apparatus by microsphere flow immunofluorescence
Time Frame
3months
Title
ImmunoglobulinA,M,G
Description
Kenza 240 TX for detection of immunoglobulin
Time Frame
3 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Mohamed, master
Organizational Affiliation
Physiotherapist at Shoubra general hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cupping Therapy on Immune System in Post Covid -19

We'll reach out to this number within 24 hrs