<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/NCT04401202</url>
  </required_header>
  <id_info>
    <org_study_id>266-20</org_study_id>
    <nct_id>NCT04401202</nct_id>
  </id_info>
  <brief_title>Nigella Sativa in COVID-19</brief_title>
  <official_title>Effects of Nigella Sativa as a Treatment of Patients With Upper Respiratory Tract Infection Caused by SARS-coronavirus-2: a Prospective, Randomized, Open-label, Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz University</source>
  <oversight_info>
    <has_dmc>No</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>
      Natural products with immunomodulation and antiviral activity showed a promising improvement&#xD;
      in the outcomes of some viral infectious diseases both in preclinical and primitive clinical&#xD;
      studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil&#xD;
      towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study&#xD;
      will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be&#xD;
      supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary&#xD;
      outcome will be the proportion of patients who clinically recovered on day 14. The secondary&#xD;
      outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes&#xD;
      occurred, NS supplementation may be recommended as an add-on to standard care protocol to&#xD;
      enhance the recovery from COVID-19 disease in the current emerging situation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Prospective, randomized, open-label, controlled clinical study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Clinical Recovery Within 14 Days After Randomization</measure>
    <time_frame>Day 14</time_frame>
    <description>The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Days to Recovery</measure>
    <time_frame>Day 14</time_frame>
    <description>The number of days to recovery (number of symptomatic days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Each Symptom</measure>
    <time_frame>Day 14</time_frame>
    <description>Duration of each symptom in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>Day 14</time_frame>
    <description>Side effects from the investigational treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Admission Due to Disease Complications</measure>
    <time_frame>Day 14</time_frame>
    <description>High severity of COVID-19 (mild cases does not require hospitalization)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>NSO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nigella sativa oil</intervention_name>
    <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
    <arm_group_label>NSO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with mild COVID19 upper respiratory tract infection and with no evidence of&#xD;
             pneumonia&#xD;
&#xD;
          -  Adult (18 Years and above)&#xD;
&#xD;
          -  Written informed consent prior to initiation of any study procedures by the patient&#xD;
             (or legally authorized representative).&#xD;
&#xD;
          -  Understands and agrees to comply with planned study procedures.&#xD;
&#xD;
          -  Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by&#xD;
             polymerase chain reaction (PCR) available at KAUH.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pneumonia or severe illness requiring admission to ICU.&#xD;
&#xD;
          -  Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) &lt; 30)&#xD;
             or end stage renal disease requiring dialysis&#xD;
&#xD;
          -  Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) &gt; 5&#xD;
             times the upper limit of normal).&#xD;
&#xD;
          -  Pregnancy or breast feeding.&#xD;
&#xD;
          -  Anticipated transfer to another hospital which is not a study site within 72 hours.&#xD;
&#xD;
          -  Allergy to any study medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King Abdulaziz University Hospital</name>
      <address>
        <city>Jeddah</city>
        <zip>21589</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <results_first_submitted>May 23, 2021</results_first_submitted>
  <results_first_submitted_qc>May 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 26, 2021</results_first_posted>
  <last_update_submitted>May 25, 2021</last_update_submitted>
  <last_update_submitted_qc>May 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Dr Abdulrahman E. Koshak</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Nigella sativa</keyword>
  <keyword>Herbal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT04401202/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>233 cases assessed for eligibility. 50 cases were excluded because; Asymptomatic (31), Pregnant (3), Declined to participate (n= 7), Failed communication (n= 9)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Standard of care</description>
        </group>
        <group group_id="P2">
          <title>Nigella Sativa Oil</title>
          <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Hospitalized</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nigella Sativa Oil</title>
          <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Standard of care</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="87"/>
            <count group_id="B2" value="86"/>
            <count group_id="B3" value="173"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35" spread="10"/>
                    <measurement group_id="B2" value="35" spread="11"/>
                    <measurement group_id="B3" value="35" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.1" spread="6.1"/>
                    <measurement group_id="B2" value="27.2" spread="5.5"/>
                    <measurement group_id="B3" value="27.1" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-enrollment days</title>
          <description>The time from the first day of symptoms until the day of enrollment</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.5" spread="2.1"/>
                    <measurement group_id="B2" value="4" spread="3.1"/>
                    <measurement group_id="B3" value="3.7" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Clinical Recovery Within 14 Days After Randomization</title>
        <description>The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nigella Sativa Oil</title>
            <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Recovery Within 14 Days After Randomization</title>
          <description>The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Days to Recovery</title>
        <description>The number of days to recovery (number of symptomatic days)</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nigella Sativa Oil</title>
            <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Days to Recovery</title>
          <description>The number of days to recovery (number of symptomatic days)</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="8" upper_limit="14"/>
                    <measurement group_id="O2" value="14" lower_limit="11" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Each Symptom</title>
        <description>Duration of each symptom in days</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nigella Sativa Oil</title>
            <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days&#xD;
Nigella sativa oil: Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Each Symptom</title>
          <description>Duration of each symptom in days</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anosmia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="3.9"/>
                    <measurement group_id="O2" value="10.4" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Runny nose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.6"/>
                    <measurement group_id="O2" value="3.7" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="2.9"/>
                    <measurement group_id="O2" value="5.5" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1"/>
                    <measurement group_id="O2" value="4.9" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Side Effects</title>
        <description>Side effects from the investigational treatment</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nigella Sativa Oil</title>
            <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Side Effects</title>
          <description>Side effects from the investigational treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Admission Due to Disease Complications</title>
        <description>High severity of COVID-19 (mild cases does not require hospitalization)</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nigella Sativa Oil</title>
            <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Admission Due to Disease Complications</title>
          <description>High severity of COVID-19 (mild cases does not require hospitalization)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nigella Sativa Oil</title>
          <description>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Standard of care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal symptoms</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Abdulrahman Koshak</name_or_title>
      <organization>King Abdulaziz University</organization>
      <phone>0543292333</phone>
      <email>aekoshak@kau.edu.sa</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04401202
org study id: 266-20
nct id: NCT04401202
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Natural products with immunomodulation and antiviral activity showed a promising improvement
      in the outcomes of some viral infectious diseases both in preclinical and primitive clinical
      studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil
      towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study
      will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be
      supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary
      outcome will be the proportion of patients who clinically recovered on day 14. The secondary
      outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes
      occurred, NS supplementation may be recommended as an add-on to standard care protocol to
      enhance the recovery from COVID-19 disease in the current emerging situation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, open-label, controlled clinical study
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization
time frame: Day 14
description: The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)
measure: The Number of Days to Recovery
time frame: Day 14
description: The number of days to recovery (number of symptomatic days)
measure: Duration of Each Symptom
time frame: Day 14
description: Duration of each symptom in days
measure: Side Effects
time frame: Day 14
description: Side effects from the investigational treatment
measure: Hospital Admission Due to Disease Complications
time frame: Day 14
description: High severity of COVID-19 (mild cases does not require hospitalization)
arm group label: NSO
arm group type: Experimental
description: Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
arm group label: Control
arm group type: No Intervention
description: Standard of care
intervention type: Dietary Supplement
intervention name: Nigella sativa oil
description: Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
arm group label: NSO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Dr Abdulrahman E. Koshak
investigator title: Assistant Professor
mesh term: COVID-19
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 