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Recruitment centers
#1
Name of recruitment center - English: Hospital of Vali-e Asr Arak
Name of recruitment center - Persian: بیمارستان حضرت ولی عصر اراک
Full name of responsible person - English: Dr. Mohammad Arjomandzadegan
Full name of responsible person - Persian: دکتر محمدارجمندزادگان
Street address - English: basij
Street address - Persian: بسیج
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Fax: +98 86 3417 3505
Email: mmatinam81@yahoo.com
Web page address:
Name of recruitment center - English: Hospital of Vali-e Asr Arak
Name of recruitment center - Persian: بیمارستان حضرت ولی عصر اراک
Full name of responsible person - English: Dr. Mohammad Arjomandzadegan
Full name of responsible person - Persian: دکتر محمدارجمندزادگان
Street address - English: Basij
Street address - Persian: بسیج
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Fax: +98 86 3417 3505
Email: mmatinam81@yahoo.com
Web page address:
Name of recruitment center - English: Hospital of Vali-e Asr Arak Name of recruitment center - Persian: بیمارستان حضرت ولی عصر اراک Full name of responsible person - English: Dr. Mohammad Arjomandzadegan Full name of responsible person - Persian: دکتر محمدارجمندزادگان Street address - English: basijBasij Street address - Persian: بسیج City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3417 3505 Fax: +98 86 3417 3505 Email: mmatinam81@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Arjomandzadegan
Full name of responsible person - Persian: معاون پژوهشی دانشگاه علوم پزشکی اراک : دکتر محمد ارجمندزادگان
Street address - English: basij
Street address - Persian: بسیج
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Fax: +98 86 3417 3505
Email: arjomandzadegan@arakmu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Assistant of Arak University of Medical Sciences:
Name of organization / entity - Persian: معاون پژوهشی دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Research Assistant of Arak University of Medical Sciences:Dr. Mohammad Arjomandzadegan
Full name of responsible person - Persian: معاون پژوهشی دانشگاه علوم پزشکی اراک : دکتر محمد ارجمندزادگان
Street address - English: basij
Street address - Persian: بسیج
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Fax: +98 86 3417 3505
Email: arjomandzadegan@arakmu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Research Assistant of Arak University of Medical Sciences: Name of organization / entity - Persian: معاون پژوهشی دانشگاه علوم پزشکی اراک Full name of responsible person - English: Research Assistant of Arak University of Medical Sciences:Dr. Mohammad Arjomandzadegan Full name of responsible person - Persian: معاون پژوهشی دانشگاه علوم پزشکی اراک : دکتر محمد ارجمندزادگان Street address - English: basij Street address - Persian: بسیج City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3417 3505 Fax: +98 86 3417 3505 Email: arjomandzadegan@arakmu.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ghasem Habibi
Full name of responsible person - Persian: قاسم حبیبی
Position - English: Research Assistant
Position - Persian: دستیار پژوهش
Latest degree: med_doctor
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک، مرکز تحقیقات بیماریهای عفونی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Mobile: +98 912 024 9261
Fax: +98 86 3417 3505
Email: ghasemhabibi.chem@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ghasem Habibi
Full name of responsible person - Persian: قاسم حبیبی
Position - English: Research Assistant
Position - Persian: دستیار پژوهش
Latest degree: bachelor
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک، مرکز تحقیقات بیماریهای عفونی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Mobile: +98 912 024 9261
Fax: +98 86 3417 3505
Email: ghasemhabibi.chem@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ghasem Habibi Full name of responsible person - Persian: قاسم حبیبی Position - English: Research Assistant Position - Persian: دستیار پژوهش Latest degree: med_doctorbachelor Area of specialty/work: 58 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک، مرکز تحقیقات بیماریهای عفونی اراک City - English: Arak City - Persian: اراک Province: Markazi Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3417 3505 Mobile: +98 912 024 9261 Fax: +98 86 3417 3505 Email: ghasemhabibi.chem@gmail.com Web page address:
Protocol summary
Study aim
Evaluation of the effect of essential oil on the prevention of second-degree burn wound infection
Design
Among the incidents that endanger the health and life of humans, burn injury is one of the hardest of them. This study is a study in which a thyme medicine herb is used to complete the treatment of burn patients. So that patients with burns, in addition to fulfilling the orders of the respected physician and taking the prescribed medications for them, the soluble thyme essential oil will be placed on the wounds of burn patients.
The use of herbal medicines and essential oils has long been traditionally used and the benefits of it are now of great interest to researchers. Previously, by the same group of researchers, the same thing has been done on a laboratory mouse and there are significant therapeutic effects observed.
Settings and conduct
Clinics and burn wards of Vali Asr Hospital in Arak are included in the plan.
Participants/Inclusion and exclusion criteria
Age from 2 to 10 years old, no underlying disease other than diabetes, first-degree and two-layer and deep burn wounds
Intervention groups
Invention group: Patient with second-degree burn wound, out- patients or In-patients in Valiasr Hospital, aged 2 to 10 years, patients of both sexes will be treated by silver sulphophylazine ointment as well as by diluted Thyme essential oil.
Control group: patients with second-degree burns, out- patients or In-patients, who only receive treatment only with silver sulphophylazine ointment .
Main outcome variables
Evaluation and comparing the size of the wound between both groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161017030336N1
Registration date:2018-12-03, 1397/09/12
Registration timing:registered_while_recruiting
Last update:2018-12-20, 1397/09/29
Update count:1
Registration date
2018-12-03, 1397/09/12
Registrant information
Name
Ghasem Habibi
Name of organization / entity
Islamic azad university
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3208
Email address
dr.habibi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Zataria thyme essential oil on controlling inflammation of second degree burn wounds in children
Public title
Effects of Zataria thyme essential oil on controlling inflammation of second degree burn wounds in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 2 and 10 years old.
Having no underlying disease other than diabetes.
The presence of first and second degree superficial burns.
Exclusion criteria:
Unwillingness to continue treatment
Age
From 2 years old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Control and intervention groups will be selected randomly using random number table.
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 Arak University of Medical Sciences
Street address
Basidj Bridge, Sadasht.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.ARAKMU.REC.1396.217
Health conditions studied
1
Description of health condition studied
Burn of second degree of head and neck
ICD-10 code
T20.2
ICD-10 code description
Burn of second degree of head and neck
2
Description of health condition studied
Burn of second degree of trunk
ICD-10 code
T21.2
ICD-10 code description
Burn of second degree of trunk
3
Description of health condition studied
Burn of second degree of shoulder and upper limb
ICD-10 code
T22.2
ICD-10 code description
Burn of second degree of shoulder and upper limb
4
Description of health condition studied
Burn of second degree of wrist and hand
ICD-10 code
T23.2
ICD-10 code description
Burn of second degree of wrist and hand
5
Description of health condition studied
Burn of second degree of hip and lower limb
ICD-10 code
T24.2
ICD-10 code description
Burn of second degree of lower limb, except ankle and foot
6
Description of health condition studied
Burn of second degree of ankle and foot
ICD-10 code
T25.2
ICD-10 code description
Burn of second degree of ankle and foot
Primary outcomes
1
Description
Wound surface
Timepoint
The ulcer would be follow up during two weeks and at the end of three days the ulcer will be assessed.
Method of measurement
photography will be done by camera from patients wounds.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group is treated with normal saline and silvered ointment. In addition, spraying diluted thyme essential oil spray 1-2 times depending on the patient's condition. Wound healing condition is checked.
Category
Treatment - Drugs
2
Description
Control group: This group is washed with normal saline and with silver ointment. they receive. Then sterile gas impregnated with silver sulfadiarin ointment is laid on the wound and closed with the band. This is done 1-2 times a day, depending on the patient's condition. The condition for wound healing is checked.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital of Vali-e Asr Arak
Full name of responsible person
Dr. Mohammad Arjomandzadegan
Street address
Basij
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
+98 86 3417 3505
Email
mmatinam81@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistant of Arak University of Medical Sciences:
Full name of responsible person
Research Assistant of Arak University of Medical Sciences:Dr. Mohammad Arjomandzadegan
Street address
basij
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
+98 86 3417 3505
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
2940
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ghasem Habibi
Position
Research Assistant
Latest degree
Bachelor
Other areas of specialty/work
Traditional Medicine
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
+98 86 3417 3505
Email
ghasemhabibi.chem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Mohammad Arjomandzadegan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
+98 86 3417 3505
Email
mmatinam81@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marajan Salehi
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRA
City
arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Fax
+98 86 3417 3505
Email
marjaanii1393@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available