Protocol summary

Study aim
Evaluation of the therapeutic effect of echinofora cinerea extract on cardiovascular poisoning caused by aluminum phosphide on patients referring to Shahid Rahimi Hospital on Khorramabad
Design
This study is a phase 0 clinical trial, with a sample size of 40 patients . In this study, there are two intervention groups that are divided into two intervention and control groups according to the random allocation rule, the first group will receive routine treatment of the hospital and the second group will receive routine treatment plus Echinofora cinerea
Settings and conduct
Patients exposed to aluminum phosphide, referring in emergency room or at ICU at Shahid Rahimi Hospital on Khorramabad , will be considered for inclusion criteria and then divided into two groups and unaware of intervention. One of the groups received routine hospital treatment and the other group received routine treatment plus Echinofora cinerea , the blood sample will be acquired. then, all patients will be screened for blood and urine tests as well as the ECG at the beginning and the length of the study. The predicted protocol for blood sampling is at the beginning of the admission, and it is repeated every 24 to 72 hours. Sample collected after centrifugation, freezing and at a temperature of 80 ° C - will be maintained for further measurements.the Echinofora cinerea extracts will be administrating in the form of suspension and via oral (natural or gastric tube). The duration of treatment varies from 72 hours to 1 week after admission, depending on the patient's condition.. During the study, several cardiovascular factors (HR, PP, RR, PR, QRS, QTC, ST Hight, T-Amplitude, homo dynamic parameters (arterial blood pressure (MAP), systolic pressure changes ( SBP), cardiac output (CO), ejection fraction (EF, arrhythmia, Palpitation), as well as dyspnea, sensory changes , adult respiratory distress syndrome (ARDS), acute renal and hepatic failure factors, and plasma factors related oxidative stress.
Participants/Inclusion and exclusion criteria
Include criteria Patients from 15 to 70 years old in both genders All acute and chronic exposures up to 6 months after the onset of poisoning Confirmation of oral intake and exposure to respiratory tract based on history and Clinical symptoms Exclude criteria Patients with underlying diseases, including diabetes, cardiovascular disease, respiratory failure, renal and hepatic impairment. Patients with receiving any medical care at other centers before entering the emergency room or hospital ICU
Intervention groups
There are two intervention groups in this study, the first one will receive the routine treatment of the hospital, and the second group will receive routine hospital treatment along with the Echinophora cinerea
Main outcome variables
Echinophora cinerea extract; Electrocardiographic changes; Systolic arterial pressure changes (SBP); mean arterial pressure (MAP); cardiac outflow (co); ejection fraction (EF); ARDS; Total antioxidant capacity of plasma; Plasma pH disorder; plasma troponin I; activity level of enzymes in oxidative stress; activity of enzymes in liver damage; bilirubin; methemoglobin levels; blood glucose levels; kidney function tests; blood magnesium levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180118038426N2
Registration date: 2018-03-19, 1396/12/28
Registration timing: registered_while_recruiting

Last update: 2018-03-19, 1396/12/28
Update count: 0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Afshin Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3222 8901
Email address
nazary257@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of echinacea extract on cardiovascular poisoning caused by aluminum phosphide
Public title
chinacea extract and cardiovascular poisoning caused by aluminum phosphide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 15-70 in both genders All cases of acute and chronic exposure to 6 months after the onset of symptoms Confirmation of oral intake and respiratory exposure based on history and clinical symptoms
Exclusion criteria:
Patients with receiving any medical care at other centers, before entering the emergency room or ICU Patients with underlying illness, including: diabetes, cardiovascular disease, respiratory failure, renal and hepatic dysfunctioد
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with random allocation rule will be divided into two groups For this purpose, the researchers first set a total sample size and then randomly assigned a group of them to Group A and assigned the remainder to Group B. For example, in this study, with a sample size of 40, 20 balls for intervention group A and 20 ball for the intervention group B, and then the balls are randomly recorded without the replacement of the container and the resulting sequence is recorded.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study participants are unaware of the randomness and intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Lorestan university of medical sciences
Street address
Moalem ave, Khorramabad town
City
Khorramabad
Province
Lorestan
Postal code
6963157444
Approval date
2017-11-20, 1396/08/29
Ethics committee reference number
ir.lums.rec.1396.324

Health conditions studied

1

Description of health condition studied
posining with aluminium posphid
ICD-10 code
T 46.9
ICD-10 code description
Other and unspecified agents primarily affecting the cardiovascular system

Primary outcomes

1

Description
troponin anzyme
Timepoint
24 hours after intervention
Method of measurement
Using the Laboratory Kit

Secondary outcomes

1

Description
liver enzymes
Timepoint
at first-24-48-72 after intervention
Method of measurement
Using the Laboratory Kit

Intervention groups

1

Description
Intervention group: In the intervention group, a Echinophora cinerea extract is obtained from a dried and powdered part of the plant is given as a suspension, to patients 40mg/kg daily.
Category
Treatment - Drugs

2

Description
Control group: There is no specific intervention in the control group and no placebo is prescribed
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rahimi Hospital
Full name of responsible person
Afshin Nazari
Street address
Moalem ave, Khorramabad town
City
Khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3312 0133
Fax
+98 66 3312 0133
Email
Nazary257@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Morvat Kalani
Street address
Moalem ave, Khorramabad town
City
Khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3312 0133
Fax
+98 66 3312 0133
Email
Nazary257@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Afshin Nazari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Moalem ave, Khorramabad town
City
Khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3312 0133
Email
Nazary257@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Afshin Nazari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Moalem ave, Khorramabad town
City
Khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66330120133
Email
Nazary257@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Afshin Nazari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Moalem ave, Khorramabad town
City
Khorramabad
Province
Lorestan
Postal code
6963157444
Phone
+98 66 3312 0133
Email
Nazary257@gmail.com

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The original outcome information will be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in review articles and books allowed
From where data/document is obtainable
Afshin Nazari-Khorram Abad- Kamalwand campus -09166616669
What processes are involved for a request to access data/document
after Sending an email ، data will be sent within a week
Comments
Loading...