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临床试验/NCT05901337
NCT05901337已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年3月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
T-lymphocyte

研究概览

简要总结

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.

.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

single

入排标准

年龄范围
21 Years 至 66 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Cupping therapy with Convential medical treatment

Active Comparator

Cupping therapy with Convential medical treatment

干预措施: Cupping therapy with convential medical treatment (Combination Product)

Cupping therapy with Convential medical treatment

Active Comparator

Cupping therapy with Convential medical treatment

干预措施: Convential medical treatment (Drug)

Convential medical treatment

Active Comparator

Convential medical treatment

干预措施: Cupping therapy with convential medical treatment (Combination Product)

Convential medical treatment

Active Comparator

Convential medical treatment

干预措施: Convential medical treatment (Drug)

结局指标

主要结局

T-lymphocyte

时间窗: 3months

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

Serum Cytokine

时间窗: 3months

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

ImmunoglobulinA,M,G

时间窗: 3 months

Kenza 240 TX for detection of immunoglobulin

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Mohamed Abd ElZahr

Dr

Cairo University

研究点 (1)

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