Protocol summary
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Study aim
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Determining the effect of warm cupping on the clinical symptoms of asthma in adults aged 18-60 years
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Design
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Patients aged 18 to 60 years with mild to moderate asthma who refer to the medical centers of Shahid Sadoughi University of Medical Sciences in Yazd, who refer to the research project as an outpatient during the implementation of the project, are confirmed by a pulmonary specialist through a history and clinical examination and are introduced to the researcher for the project. Firstly, the study exclusion and exclusion criteria are reviewed, and if a patient meets the eligibility criteria, they are entered into the study and informed consent is obtained from them.
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Settings and conduct
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Shahid Rahnamun Hospital and Hazrat Fatemeh Al-Zahra Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with mild and moderate asthma; Patients who have stable conditions and do not need hospitalization; The age of the patients should be 18 to 60 years. Exclusion criteria: Inability to express the severity of symptoms; A patient who needs hospitalization.
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Intervention groups
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Control group: Received routine treatment for asthma, including bronchodilators and inhaled corticosteroids
Intervention group: Received routine treatment like the control group, plus warm cupping twice in the first week, 3 days apart.
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Main outcome variables
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Number of shortness of breath per week
The amount of salbutamol spray
Asthma control rate
Exacerbation of asthma
General information
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Reason for update
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Correcting some spelling errors
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230413057896N1
Registration date:
2025-04-24, 1404/02/04
Registration timing:
prospective
Last update:
2025-07-24, 1404/05/02
Update count:
1
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Registration date
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2025-04-24, 1404/02/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-04-26, 1404/02/06
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Expected recruitment end date
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2025-07-11, 1404/04/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of warm cupping on the symptoms of asthma in adults aged 18-60
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Public title
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The effect of warm cupping in Asthma
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Mild to moderate asthma
Age 18-60 years
Willingness to use warm cupping therapy
Having a stable hemodynamic physical condition
Exclusion criteria:
Pregnancy
Breastfeeding
Chronic heart disease
Patients who decide to withdraw from the study by personal request
Inability to express the severity of symptoms
The patient requires hospitalization
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individual randomization: People who enter the study are randomly assigned to the control and intervention groups, one at a time, regardless of gender.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-04, 1401/12/13
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Ethics committee reference number
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IR.SSU.SRH.REC.1401.025
Health conditions studied
1
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Description of health condition studied
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Asthma
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ICD-10 code
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J45
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ICD-10 code description
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Asthma
Primary outcomes
1
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Description
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Number of shortness of breath per week
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Timepoint
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Start studying once, the end of the first week, the end of the fifth week, the end of the ninth truth from the beginning of the study
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Method of measurement
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Asthma Control Test Questionnaire
Secondary outcomes
1
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Description
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The amount of salbutamol spray
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Timepoint
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Start studying once, the end of the first week, the end of the fifth week, the end of the ninth truth from the beginning of the study
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Method of measurement
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ACT questionnaire
Intervention groups
1
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Description
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Intervention group: In the Department of Iranian Medicine of Shahid Sadoughi University of Medical Sciences, Yazd, the patient will be placed on a medical bed with a guard lying on the stomach or in a prone position. After disinfecting the place where the suction is performed, 5 glasses will be placed on the back of the patient in the area of the lungs on both sides of the spine. By touching these cups on the skin, after putting burning cotton in them, which creates negative pressure and vacuum, 2 to 3 centimeters of the patient's skin protrudes inside the cup. The inflatable cup stays in the lung for 15 minutes, and after 15 minutes, it is slowly removed from the body. The patients of the intervention group are inflated 2 times in the first week with an interval of 3 days.
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Category
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Treatment - Devices
2
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Description
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Control group: Treated with common asthma medications including bronchodilators and inhaled corticosteroids
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data analysis
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When the data will become available and for how long
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After finishing the project
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To whom data/document is available
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Associate professors
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Under which criteria data/document could be used
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Checking for treatment and prevention
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From where data/document is obtainable
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University
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What processes are involved for a request to access data/document
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Data analysis
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Comments
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