Covid-19 PatientsNCT05901337
Cupping Therapy on Immune System in Post Covid -19
A study testing Cupping therapy with convential medical treatment and Convential medical treatment in people with Covid-19 Patients, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 21 to 66 years
- Conditions the study is for
- Covid-19 Patients
- What is being tested?
- Cupping therapy with convential medical treatment and Convential medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Cupping Therapy on Immune System in Post Covid- 19 Patients
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. .
Read the 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
- Being tested
- Cupping therapy with convential medical treatment, Convential medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cupping therapy with convential medical treatmentCombination 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 treatmentDrug
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 .
| Study group | Role | What they receive |
|---|---|---|
| Cupping therapy with Convential medical treatment | Active comparator | Cupping therapy with Convential medical treatment Receives: Combination Product: Cupping therapy with convential medical treatment; Drug: Convential medical treatment |
| Convential medical treatment | Active comparator | Convential medical treatment Receives: Combination Product: Cupping therapy with convential medical treatment; Drug: Convential medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-lymphocyte
1- Lymphocyte subset were analyzed from fluorescence-labeled flow cytometry on a DxFLEX flow cytometry by Kenza 240 Tx
Measured: 3months
Serum Cytokine
Cytokine detection Kenza reagents were provided from a 240 TX bio lap diagnostic apparatus by microsphere flow immunofluorescence
Measured: 3months
ImmunoglobulinA,M,G
Kenza 240 TX for detection of immunoglobulin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start7 Mar 2022
- Primary completion21 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 PatientsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Abd ElZahr, Cairo University
- Investigators
- Marwa Mohamed, master, Principal investigator, Physiotherapist at Shoubra general hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901337
- Sponsor's protocol ID
- No:P.T.REC/012/003554
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cupping Therapy on Immune System in Post Covid- 19 Patients
- ClinicalTrials.gov ID
- NCT05901337
- Acronym / sponsor ID
- No:P.T.REC/012/003554
- Conditions
- Covid-19 Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cupping therapy with Convential medical treatment | Active comparator | Combination Product: Cupping therapy with convential medical treatment, Drug: Convential medical treatmentCupping therapy with Convential medical treatment |
| Convential medical treatment | Active comparator | Combination Product: Cupping therapy with convential medical treatment, Drug: Convential medical treatmentConvential medical treatment |
Who may qualify
- Ages
- 21 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (17 listed)
- History of acute or chronic infections
- Hepatobiliary diseases
- Hematological diseases
- Urinary system diseases
- Nutrition and metabolism diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cupping therapy with convential medical treatmentDevice: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 . | Combination product | Convential medical treatment, Cupping therapy with Convential medical treatment |
| Convential medical treatmentGroup 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 . | Drug | Convential medical treatment, Cupping therapy with Convential medical treatment |
Primary outcome
T-lymphocyte
Time frame: 3months
1- Lymphocyte subset were analyzed from fluorescence-labeled flow cytometry on a DxFLEX flow cytometry by Kenza 240 Tx
Serum Cytokine
Time frame: 3months
Cytokine detection Kenza reagents were provided from a 240 TX bio lap diagnostic apparatus by microsphere flow immunofluorescence
ImmunoglobulinA,M,G
Time frame: 3 months
Kenza 240 TX for detection of immunoglobulin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Mohamed, master principal investigator
Physiotherapist at Shoubra general hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cupping therapy with convential medical treatment and Convential medical treatment in people with Covid-19 Patients, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-lymphocyte (time frame: 3months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.