The effect of injectable vitamins E and C on serum cortisol levels, Interleukin-6 and duration of hospitalization in patients with severe traumatic lung contusion: Randomized Controlled Clinical Trial
Evaluation of the effect of injectable vitamin E and Con serum cortisol interleukin-6, ABG, CRP and duration of hospitalization in patients with severe pulmonary contusion, and patients with at least 2 rib fractures
Design
Clinical trial with control group with 4 parallel groups of double-blind randomized phase 3 on 200 patients. Excel software was used for refinement
Settings and conduct
At Baqitullah Hospital in Tehran and Shariati Hospital in Kashan, 200 patients with chest trauma are randomly divided into 4 groups of 50 people. And vitamin E 100 for 3 days - and the fourth group take distilled water (patients are unaware of the type of drug)
Then the inflammatory factors of interleukin 6 and arterial gases and inflammatory protein C and the length of hospitalization of patients between these 4 groups are examined.
Participants/Inclusion and exclusion criteria
Admission: Traumatized individuals over 12 years of age with a fracture of at least 2 ribs or lung contusion proven by CT scan images
Exclusion:
Patients that dont want to participate .
Intervention groups
The first group receives 100 units of vitamin E for 3 consecutive days
The second group receives 500 grams of vitamin C for 3 consecutive days
The third group receives 100 units of vitamin E and 500 grams of vitamin C for 3 consecutive days
The fourth group receives 1distilled water for 3 consecutive days
Main outcome variables
متغیر ها شامل پروتیین التهابی سی ;گاز شریانی خونی ; اینترلوکین ۶ وکورتیزول سرم و مدت بستری بیماران در بیمارستان
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200731048260N2
Registration date:2021-09-29, 1400/07/07
Registration timing:prospective
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
Benyamin Seyfari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2259 6152
Email address
seyfari@ptsoc.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-17, 1400/07/25
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of injectable vitamins E and C on serum cortisol levels, Interleukin-6 and duration of hospitalization in patients with severe traumatic lung contusion: Randomized Controlled Clinical Trial
Public title
The effect of injectable vitamins E and C on serum cortisol levels, Interleukin-6 and duration of hospitalization in patients with severe traumatic lung contusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
trauma patients with at least 2 broken ribs
trauma patients with lung cantusions based on ct scan pictures
Exclusion criteria:
patients under 12
patients that dont want to participate
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
We divide 1 to 200 into 4 groups randomly with the help of Excel ( randomize between ) and based on that, we divide the patients admitted to the study into these 4 groups.
In a way, people themselves are not aware of the mentioned wedge
Blinding (investigator's opinion)
Double blinded
Blinding description
Trauma patients admitted to the study will not have any information about the type of substance received and will be explained that the drug used is harmless .
The person who first tests the laboratory results also does not know the type of drug or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of baqiyatallah hospital
Street address
NO28 . JAHANTAB AVE .TEHRAN.
City
tehran
Province
Tehran
Postal code
1939883614
Approval date
2021-03-02, 1399/12/12
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.065
Health conditions studied
1
Description of health condition studied
Trauma patients with rib fracture and lung contusions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Interlukin 6
Timepoint
first ,second and third day of addmition
Method of measurement
Labrotory
2
Description
c reactive protein (crp)
Timepoint
first ,second and third day of addmition
Method of measurement
Labrotory
3
Description
Serum cortisol
Timepoint
first ,second and third day of addmition
Method of measurement
Labrotory
4
Description
Atrial Bl00d Gasses (ABG)
Timepoint
first ,second and third day of addmition
Method of measurement
Lab test
5
Description
Duration of hospitalization
Timepoint
Upon clearance
Method of measurement
Based on the number of days of hospitalization
Secondary outcomes
1
Description
Duration of hospitalization in the intensive care unit
Timepoint
When leaving the intensive care unit
Method of measurement
Based on the number of hospitalization days
Intervention groups
1
Description
Intervention group1: 50 people receive 500 mg of vitamin C intramuscularly
Category
Treatment - Drugs
2
Description
Intervention group2: 50 people receive 100 iu of vitamin E intramuscularly
Category
Treatment - Drugs
3
Description
Intervention group3: 50 people receive 100 iu of vitamin E and 500 mg vit C intramuscularly
Category
Treatment - Drugs
4
Description
Control group: 50 people receive distilled muscle water
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiatallah hospital
Full name of responsible person
Benyamin Seyfari
Street address
Tehran . Gheytariyeh South .Jahantab St. Goche Biglerpour West . No. 28 .Unit 10
City
Tehran
Province
Tehran
Postal code
1939883614
Phone
+98 21 2259 6152
Email
benyaminseyfari1369@yahoo.com
2
Recruitment center
Name of recruitment center
Beheshti hospital Of Kashan
Full name of responsible person
Benyamin Seyfari
Street address
Tehran .Gheytariyeh South . Jahantab St. Goche Biglerpour West . No. 28 . Unit 10
City
Tehran
Province
Tehran
Postal code
1939883614
Phone
+98 21 2259 6152
Email
benyaminseyfari1369@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr masoud Khosh mohabbat
Street address
Tehran . Baghiatolah haspital
City
Tehran
Province
Tehran
Postal code
1939883614
Phone
+98 21 2259 6152
Email
benyaminseyfari1369@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Benyamin Seyfari
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Unit 10 , No 28 , west biglaripur , jahantab street , ghetrarie jonubi
City
Tehran
Province
Tehran
Postal code
۱۹۳۹۸۸۳۶۱۴
Phone
+98 21 2259 6152
Fax
Email
seyfari@ptsoc.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Benyamin Seyfari
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Unit 10 , No 28 , west biglaripur , jahantab street , ghetrarie jonubi
City
Tehran
Province
Tehran
Postal code
۱۹۳۹۸۸۳۶۱۴
Phone
+98 21 2259 6152
Fax
Email
seyfari@ptsoc.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Benyamin Seyfari
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Unit 10 , No 28 , west biglaripur , jahantab street , ghetrarie jonubi
City
Tehran
Province
Tehran
Postal code
۱۹۳۹۸۸۳۶۱۴
Phone
+98 21 2259 6152
Fax
Email
seyfari@ptsoc.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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available