<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04499885</url>
  </required_header>
  <id_info>
    <org_study_id>ghada protocol</org_study_id>
    <nct_id>NCT04499885</nct_id>
  </id_info>
  <brief_title>Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning</brief_title>
  <official_title>Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sherief Abd-Elsalam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to investigate the Potential Role of Gastric Lavage by Paraffin Oil in Acute&#xD;
      Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 10, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2030</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of deaths</measure>
    <time_frame>6 months</time_frame>
    <description>The number of deaths</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Toxicity, Drug</condition>
  <arm_group>
    <arm_group_label>Paraffin oil gastric lavafe</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline gastric lavage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gastric lavage with saline and sodium bicarbonate</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paraffin oil gastric lavage</intervention_name>
    <description>Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution</description>
    <arm_group_label>Paraffin oil gastric lavafe</arm_group_label>
    <other_name>Paraffin oil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gastric lavage with saline and sodium bicarbonate 8.4%</intervention_name>
    <description>Gastric lavage with saline and sodium bicarbonate 8.4%</description>
    <arm_group_label>Saline gastric lavage</arm_group_label>
    <other_name>Saline gastric lavage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients with symptomatic acute aluminum phosphide poisoning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Pregnant and lactating women&#xD;
&#xD;
               -  Asymptomatic patients with history of acute aluminum phosphide exposure.&#xD;
&#xD;
               -  Patients with ingestion or exposure to other substances in addition to aluminum&#xD;
                  phosphide.&#xD;
&#xD;
               -  Patients with other major medical conditions (e.g. cardiovascular disease, renal&#xD;
                  or hepatic failure).&#xD;
&#xD;
               -  Patients with previous medical intervention (had gastric lavage in any medical&#xD;
                  center before admission).&#xD;
&#xD;
               -  Patients with disturbed consciousness level&#xD;
&#xD;
               -  Patients with post cardiac arrest cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadia Ezzat Helal, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Forensic medicine Department- Tanta University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayman Nagy, ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Forensic medicine Department- Tanta University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ghada N. El-Sarnagawy, ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Forensic medicine Department- Tanta University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherief Abd-Elsalam, ass. prof.</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sherief abd-elsalam, ass. prof</last_name>
      <phone>00201147773440</phone>
      <email>sheroefabdelsalam@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Ass. Prof. Tropical Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mineral Oil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04499885
org study id: ghada protocol
nct id: NCT04499885
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning.
The study aims to investigate the Potential Role of Gastric Lavage by Paraffin Oil in Acute
      Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of deaths
time frame: 6 months
description: The number of deaths
arm group label: Paraffin oil gastric lavafe
arm group type: Active Comparator
description: Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution
arm group label: Saline gastric lavage
arm group type: Active Comparator
description: Gastric lavage with saline and sodium bicarbonate
intervention type: Device
intervention name: Paraffin oil gastric lavage
description: Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution
arm group label: Paraffin oil gastric lavafe
other name: Paraffin oil
intervention type: Device
intervention name: Gastric lavage with saline and sodium bicarbonate 8.4%
description: Gastric lavage with saline and sodium bicarbonate 8.4%
arm group label: Saline gastric lavage
other name: Saline gastric lavage
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nadia Ezzat Helal, Ass. Prof.
role: Principal Investigator
affiliation: Forensic medicine Department- Tanta University
last name: Ayman Nagy, ass. Prof.
role: Principal Investigator
affiliation: Forensic medicine Department- Tanta University
last name: Ghada N. El-Sarnagawy, ass. Prof.
role: Principal Investigator
affiliation: Forensic medicine Department- Tanta University
last name: Sherief Abd-Elsalam, ass. prof.
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Ass. Prof. Tropical Medicine
mesh term: Poisoning
mesh term: Drug-Related Side Effects and Adverse Reactions
mesh term: Mineral Oil
sharing ipd: No