NCT05901337

Brief Summary

Purpose of this study is to investigate

  1. 1.The effect of Dry cupping therapy on T-Lymphocyte in post covid-19 patients.
  2. 2.The effect of Dry cupping therapy on serum Cytokine in post covid-19 patients.
  3. 3.The effect of Dry cupping therapy on Immunoglobulin IgA.
  4. 4.The effect of Dry cupping therapy on Immunoglobulin IgM.
  5. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

June 11, 2023

Last Update Submit

June 11, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • T-lymphocyte

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

    3months

  • Serum Cytokine

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

    3months

  • ImmunoglobulinA,M,G

    Kenza 240 TX for detection of immunoglobulin

    3 months

Study Arms (2)

Cupping therapy with Convential medical treatment

ACTIVE COMPARATOR

Cupping therapy with Convential medical treatment

Combination Product: Cupping therapy with convential medical treatmentDrug: Convential medical treatment

Convential medical treatment

ACTIVE COMPARATOR

Convential medical treatment

Combination Product: Cupping therapy with convential medical treatmentDrug: Convential medical treatment

Interventions

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 treatmentCupping therapy with 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 .

Convential medical treatmentCupping therapy with Convential medical treatment

Eligibility Criteria

Age21 Years - 66 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Egypt

Location

MeSH Terms

Interventions

Cupping Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Marwa Mohamed, master

    Physiotherapist at Shoubra general hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 11, 2023

First Posted

June 13, 2023

Study Start

March 7, 2022

Primary Completion

June 21, 2022

Study Completion

June 1, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations