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The effect of wet cupping on clinical manifestation of the adult asthma 18-60 ‎years ‎

Protocol summary

Study aim
Comparison of the effect of cupping on clinical symptoms of 18-60 years old adult asthma
Design
A clinical trial with a control group, parallel, without blinding, randomized sample size: 76
Settings and conduct
Patients between the ages of 18 and 60 with mild to moderate asthma who are referred to an outpatient clinic at Loghman Hospital are randomly divided into two groups: intervention and control. The disease is confirmed by a pulmonary subspecialty with a history and clinical examination. The sample size in each group is 36 people. Before entering the study, a written consent form and background information will be obtained. The Standard Questionnaire (ACT) is completed before the intervention, at the end of the first, second, fourth, sixth and end of the eighth week after the intervention. At the end of the study and sampling, the relevant information is extracted and the necessary analyzes are performed. .
Participants/Inclusion and exclusion criteria
Entry criteria: patients with mild to moderate asthma between the ages of 18 and 60 old; patients with stable conditions The satisfaction of the person to enter the study. Criteria for not entering the study: patients with severe asthma and need hospitalization; the person has conditions such as CF, bronchopulmonary, dysplasia, heart failure, pulmonary embolism, bronchotracheomalacia, bronchiectasis, sarcoidosis, and diabetes. A consumer of drugs such as aspirin, beta-blockers, and NSAIDs; cupping less than a month; patients with a history of coagulation disorders; history of anemia; weak immune system; smokers; breastfeeding or pregnancy.
Intervention groups
Patients are divided into control group (only for asthma routines) and intervention group (which, in addition to veterinarians, is a cupping session).
Main outcome variables
Assess the patient's quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181110041600N1
Registration date: 2020-07-15, 1399/04/25
Registration timing: prospective

Last update: 2020-07-15, 1399/04/25
Update count: 0
Registration date
2020-07-15, 1399/04/25
Registrant information
Name
Abbas Joushan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 2334
Email address
dr.a.joushan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of wet cupping on clinical manifestation of the adult asthma 18-60 ‎years ‎
Public title
Evaluation of the effect of cupping on clinical symptoms of adult asthma 18-60 years
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate asthma are diagnosed by a pulmonary specialist. Patients with stable conditions. The patient's age is 18 to 60 years old.
Exclusion criteria:
Patients with severe asthma and need hospitalization Patients with underlying conditions such as CF, bronchopulmonary, dysplasia, heart failure, pulmonary embolism, bronchotracheomalacia, bronchiectasis, sarcoidosis, and diabetes Consumer of drugs such as aspirin, beta-blockers and NSAIDs Cupping less than a month Patients with a history of coagulation disorders Patients with a history of anemia Weak immune system Smokers Breastfeeding Pregnancy Inability to speak Persian
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after calculating the final sample size of the study, random chains are generated on the basis of simple random series using quadratic random blocks for both intervention and control groups. For the generated random chain, a corresponding code will be generated for each sequence. This code contains two letters of the alphabet and one number. Anonymous codes will be posted on the forms before the study begins. During the study, patients were divided into two groups according to the order of entry of patients and randomization sheets (merely including anonymous codes). Patients in the intervention group will receive wet cupping in addition to routine treatment. Patients in the control group will receive only routine treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-07-07, 1399/04/17
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.351

Health conditions studied

1

Description of health condition studied
Mild to moderate asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Evaluation of clinical symptoms of patients with mild to moderate asthma
Timepoint
At week zero and at the end of weeks one, two, four, six and eight
Method of measurement
Asthma Control Test

Secondary outcomes

1

Description
Evaluation of clinical symptoms of patients with mild to moderate asthma
Timepoint
In the week of zero and at the end of the first, second, fourth, sixth and eighth weeks
Method of measurement
Asthma control questionnaire

Intervention groups

1

Description
Intervention group: The intervention group is being treated with standard asthma medications, which will use 25.25 micrograms of 2 puff serum sprays every 12 hours, and if needed, they can also use salbutamol spray with more cupping (cupping between the two shoulders) cupping in It is performed on one of the 17th, 19th and 21st lunar months. The intervention is performed only once. Each cupping period involves 3 stages of blood sampling and lasts approximately 10 minutes.
Category
Treatment - Devices

2

Description
Control group: The control group is only treated with standard asthma medications, using a 25.25 microgram 2-puff serum spray every 12 hours, and they can also use salbutamol spray if needed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Abbas Joushan
Street address
Loghman Hakim Hospital, Lashkar Ave.
City
Tehran
Province
Tehran
Postal code
1594666519
Phone
+98 21 8889 2334
Email
dr.a.joushan@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Esmaili
Street address
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciencesm No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Joushan
Position
Physician, PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciencesm No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.a.joushan@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Joushan
Position
Physician, PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciencesm No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.a.joushan@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Joushan
Position
Physician, PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciencesm No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 3521
Email
dr.a.joushan@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publishing results in the form of a PhD thesis and an article indexing in ISI
When the data will become available and for how long
after PhD thesis defence
To whom data/document is available
Public
Under which criteria data/document could be used
for research reasons
From where data/document is obtainable
Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
approving by the responsible officer
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