The aim of this study is evaluation of effects of Borage seed’s oil on inflammatory cytokines levels in acute respiratory distress syndrome (ARDS) patients. According to the Berlin, patients were diagnosed for acute respiratory distress syndrome, were enrolled. Patients with Liver diseases, blood coagulation disorders, gastrointestinal bleeding, inflammatory bowel disease, diarrhea and other gastrointestinal malignancies under Routine treatment of inflammatory diseases were excluded from the study. In a randomized clinical trial, 30patients in ICU were assigned randomly to receive 2 gr Borage seed extract or placebo (control group) for five days. Inflammatory cytokine levels causing acute respiratory distress syndrome, including CXCL-8 and TNF -a and IL -6 were measured to compare the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072420592N7
Registration date:2017-06-05, 1396/03/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-05, 1396/03/15
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2016-06-01, 1395/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of Borageseed’s oiloninflammatory on cytokines levels in acute respiratory distress syndrome (ARDS) patients
Public title
Evaluating the effects of Borageseed’s oiloninflammatory in treatment of acute respiratory distress syndrome (ARDS) patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclution Criteria:
Patients with acute respiratory distress syndrome.
Exclution Criteria:
Liver diseases; blood coagulation disorders;gastrointestinal bleeding; inflammatory bowel disease; diarrhea and other gastrointestinal malignancies under Routine treatment of inflammatory diseases
Age
From 16 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-08-06, 1395/05/16
Ethics committee reference number
IR.SBMU.NRITLD.REC.1395.240
Health conditions studied
1
Description of health condition studied
Acute Respiratory Distress Syndrome (ARDS)
ICD-10 code
U04.9
ICD-10 code description
Severe acute respiratory syndrome [SARS], unspecified
Primary outcomes
1
Description
interlukiun 8
Timepoint
In start of the study and 3th and 5th days.
Method of measurement
Human Boster Kit
Secondary outcomes
1
Description
Tumor necrosis factor alpha
Timepoint
In start of the study and 3th and 5th days
Method of measurement
Kit
Intervention groups
1
Description
Intervention:
The patients in intervention group received 2 gr daily of Borage seed extract for 5 days.
Category
Treatment - Drugs
2
Description
Control:
The patients in control group received 2 gr daily of placebo for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Sadoughi, investigator
Street address
Shahid Beheshti University of Medical Sciences, Tabnak Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammadreza Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammad reza hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2111 9279
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammadreza Hashemian
Position
Associate Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)