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Study aim
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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
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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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