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Explaining “OrameHarreRiyavi”(acute pulmonary edema) and investigating the effect of Hijamat (wet cupping therapy) on acute inhalant intoxication with chlorine gas

Protocol summary

Study aim
Investigating the effect of “Hijamat” on acute inhalant intoxication with chlorine gas
Design
Quasi-experimental clinical trial with the sample of 60 individuals and a simple random allocation method will be used to assign participants to the experimental and control groups
Settings and conduct
Sampling will be done from patients with inhalant intoxication referring to the Intoxication Emergency Department of Loghman Hospital. After performing the necessary new medicine treatments and obtaining consent and randomization,“Hijamat” will be used as a treatment for the intervention group,only once at the patient’s visit, however the evaluation of patients in both groups will be measured and recorded in three stages, one hour, one week and one month after the intervention.Patients’ signs and symptoms will be investigated and registered through questionnaires, instrumental measurements and examination by three separate physicians, in both groups. Finally, the data will be analyzed using statistical software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Moderate to severe intoxication. Age: 2 - 60 years old. Consent to Hijamat. No history of previous pulmonary diseases or hypersensitivity syndromes Not taking any anticoagulants drugs Not consuming foods such as egg, fish, liver, pickle and dairy products during the last 12 hours. No having sex, menstruation, severe bleeding or any kind of bleeding within the last 12 hours. Exclusion criteria: Not having consent to do Hijamat. No diseases with pulmonary symptoms during the Evaluation period. Unwillingness to cooperate in the post-intervention assessment.
Intervention groups
Inhalant intoxicated patients with chlorine gas
Main outcome variables
Dyspnea, maximum exhale respiratory flow, blood oxygen saturation level, PR , RR and BP, pulmonary'sounds and other organs signs and symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200309046727N1
Registration date: 2020-12-13, 1399/09/23
Registration timing: registered_while_recruiting

Last update: 2020-12-13, 1399/09/23
Update count: 0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Khatereh Akbarimashak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6603 5204
Email address
khatereh.akbari@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Explaining “OrameHarreRiyavi”(acute pulmonary edema) and investigating the effect of Hijamat (wet cupping therapy) on acute inhalant intoxication with chlorine gas
Public title
Investigating the effect of Hijamat (wet cupping therapy) on acute pulmonary edema due to acute inhalant intoxication with chlorine gas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe inhalant intoxication with bleaching agent Age between 2 to 60 years old Consent to Hijamat (wet cupping therapy)
Exclusion criteria:
Existence of history of previous lung disease such as asthma and chronic obstructive pulmonary disease (COPD) Existence of history of hypersensitivity syndrome such as urticaria, atopic dermatitis (eczema) Having sex or menstruation, severe bleeding and any kind of bleeding within the last 12 hours Consuming foods such as egg, fish, liver, pickle and dairy products during the last 12 hours Presence of any acute or chronic illnesses in active phase Taking any anticoagulants drugs such as Aspirin, Warfarin, Plavix and Osvix
Age
From 2 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study,a simple random allocation method using Random Allocation Software (http://mahmoodsaghaie.tripod.com/softwares/randalloc.html) will be used to assign participants to the experimental and control groups.It will be done until reaching the desired sample size in each group(30 people).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Because of ethical considerations, this study is a quasi-experimental study, and the conditions, severity and method of intoxication cannot be controlled in advance

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahedUniversity
Street address
No. 364, Azadi residential complex, ETKA Alley, ShahidJavadAkbari Blvd., AzadiStreet, Tarasht
City
Tehran
Province
Tehran
Postal code
1458814376
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.SHAHED.REC.1398.130

Health conditions studied

1

Description of health condition studied
Acute Respiratory Distress Syndrome caused by chlorine gas inhalation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maximum respiratory flow
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
Peak flow meter device

2

Description
The level of oxygen saturation of peripheral blood
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
Pulse Oximeter device

3

Description
Respiratory Sounds (wheezes and crackles (rales))
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
Lung sound examination with stethoscope

4

Description
Respiratory rate
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
Examination and counting per minutes

5

Description
Puls rate
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
Examination and counting per minutes

6

Description
blood pressure
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
Mercury sphygmomanometer device

7

Description
Gastrointestinal symptoms
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
Questionnaire

8

Description
Skin and mucosal irritation symptoms
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
Questionnaire

9

Description
Neurological and cognitive symptoms
Timepoint
Before Hijamat (wet cupping therapy), and one hour, one week and one month after Hijamat (wet cupping therapy)
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: they receive Hijamat (wet cupping therapy) once between two scapulae, immediately after patient’s visit and after receiving allopathic medical treatment, with the use of a disposable cup for Hijamat (wet cupping therapy) and manual suction for 3 to 5 minutes and creating 10 millimeter skin scratches with a 15 bistoury blade, and then repeating the suction and taking 30 cc blood sampling. Then evaluating the patient’s symptoms 3 times in one hour, one week and one month after Hijamat (wet cupping therapy).
Category
Treatment - Other

2

Description
Control group: only receive allopathic medicine treatments at the beginning of the visit and then the evaluating of the patient's symptoms within one hour and one week and one month after the visit.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman e Hakim hospital
Full name of responsible person
KhaterehAkbariMashak
Street address
Loghman e Hakim hospital, Kamali Street,Lashgar cross, Southern Karegar Street
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5307
Email
kh.akbari92@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kia-Salari
Street address
PO Box:18155.159, Shahed University, Facing the shrine of Imam Khomeini, Persian Gulf highway(Tehran- Qom)
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5105
Email
kiasalari@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
KhaterehAkbariMashak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
PO Box:18155.159, Department of Traditional Medicine, Shahed University, facing the shrine of Imam Khomeini, Persian Gulf Highway(Tehran - Qom)
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Email
Kh.akbari92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
HasanNamdar
Position
Associate professor, faculty member of ShahedUniversity
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
PO Box:18155.159, Department of Traditional Medicine, Shahed University, facing the shrine of Imam Khomeini, Persian Gulf Highway(Tehran - Qom)
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Email
Dr.h.namdar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
KhaterehAkbariMashak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
PO Box:18155.159, Department of Traditional Medicine, Shahed University, facing the shrine of Imam Khomeini, Persian Gulf Highway(Tehran - Qom)
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Email
Kh.akbari92@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The study is still undergoing
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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