<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/NCT01733212</url>
  </required_header>
  <id_info>
    <org_study_id>IRB:147810</org_study_id>
    <nct_id>NCT01733212</nct_id>
  </id_info>
  <brief_title>Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients</brief_title>
  <official_title>Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joel Yarmush</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York Presbyterian Brooklyn Methodist Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      SPECIFIC AIMS&#xD;
&#xD;
        -  Assess risk factors for nausea and vomiting in c-section patients undergoing regional&#xD;
           anesthesia&#xD;
&#xD;
        -  Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in&#xD;
           the ginger and placebo groups.&#xD;
&#xD;
        -  Quantify post-operative analgesia and pruritus in the ginger and placebo groups&#xD;
&#xD;
        -  Quantify patient satisfaction of the ginger and placebo groups&#xD;
&#xD;
        -  Assess patient expectation of ginger on post-op day three&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two hundred and thirty nine ASA class I and II patients, scheduled for elective c-section&#xD;
      will be assigned randomly to receive either 1g ginger tablet PO (Group 1) or 1 g placebo PO&#xD;
      (Group 2) preoperatively, immediately before surgery. The usual preoperative anti-emetic and&#xD;
      antacid regimen will be continued for both groups. Initial blood pressure, pulse and&#xD;
      hemoglobin and hematocrit will be documented by the researcher prior to the arrival of the&#xD;
      patient into the operating room. A baseline questionnaire will be given to the patients to&#xD;
      assess risk factors for nausea and vomiting. Questions will include: age, BMI, parity, weeks&#xD;
      gestation, h/o seasickness, h/o of hyperemesis gravidrum in this or prior pregnancies, h/o&#xD;
      PONV, medical problems, any medication used within past 24 hrs, education and occupation.&#xD;
&#xD;
      Intraoperatively, both groups will receive combined spinal-epidural anesthesia in the usual&#xD;
      manner. All standard monitoring will be applied and vital signs recorded for the entirety of&#xD;
      the procedure. The number and dose of ephedrine or phenylephrine boluses and the number and&#xD;
      severity of nausea episodes (using a Visual Analog Scale (VANS)) and number of vomiting&#xD;
      episodes will be noted. In addition the following will be recorded: if uterus was&#xD;
      exteriorized, any medications used by the anesthesiologist (other than ephedrine and&#xD;
      phenylephrine), and estimated blood loss.&#xD;
&#xD;
      Postoperatively, patients will receive either a one time dose of the 1g ginger PO (Group 1)&#xD;
      or 1 g placebo PO (Group 2) 2 hours after entering the postanesthesia care unit (PACU).&#xD;
      Thirty minutes after the medication is given, patients will be asked to rate their nausea,&#xD;
      level of analgesia, and level of pruritus on a VANS, and vomiting episodes will be recorded.&#xD;
      Medications given for nausea will be continued in the post-operative period for both groups.&#xD;
      The doses of Zofran will be counted in the 24 hr postoperative period. Twenty-four hours&#xD;
      after surgery, blood will be drawn to assess hemoglobin and hematocrit as well as to assess&#xD;
      platelet function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Intra-operative and Post-operative Vomiting</measure>
    <time_frame>During surgery (1 hour) and thru 72 hours after surgery</time_frame>
    <description>Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">239</enrollment>
  <condition>Nausea</condition>
  <condition>Vomiting</condition>
  <arm_group>
    <arm_group_label>Ginger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 gm powder of ginger filled in a capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 gm of placebo pill (A capsule)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ginger</intervention_name>
    <description>Ginger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.</description>
    <arm_group_label>Ginger</arm_group_label>
    <other_name>Zingiber Officinale</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy (i.e., ASA I, or II) patients presenting for planned c-section at New York&#xD;
             Methodist Hospital&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They are unable or unwilling to take part in the study&#xD;
&#xD;
          -  They have a history of an allergy to any medications used including ginger&#xD;
&#xD;
          -  They have had any gastrointestinal surgery on the stomach, small intestine, or gall&#xD;
             bladder.&#xD;
&#xD;
          -  They have any history of bleeding disorder, (i.e., Hemophilia A/B, ITP, etc.)&#xD;
&#xD;
          -  They have a contraindication to intrathecal or epidural anesthesia. ( i.e., Arnold-&#xD;
             Chiari malformation, etc.)&#xD;
&#xD;
          -  They are unable to understand instructions or questions related to study&#xD;
&#xD;
          -  ASA III or IV patients&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Weinberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Presbyterian Brooklyn Methodist Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Methodist Hospital</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>April 30, 2013</results_first_submitted>
  <results_first_submitted_qc>April 10, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 11, 2018</results_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>New York Presbyterian Brooklyn Methodist Hospital</investigator_affiliation>
    <investigator_full_name>Joel Yarmush</investigator_full_name>
    <investigator_title>Attending Physician, Program Director (Anesthesiology)</investigator_title>
  </responsible_party>
  <keyword>Nausea</keyword>
  <keyword>Vomiting</keyword>
  <keyword>Cesaraen</keyword>
  <keyword>Ginger</keyword>
  <keyword>cesarean section</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment period: June 03, 2010 to April 12, 2011 Location: New York Methodist Hospital, Department of Obstetrics and Gynecology</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ginger</title>
          <description>2 gm powder of ginger filled in a capsule</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>2 gm of placebo pill (A capsule)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ginger</title>
          <description>2 gm powder of ginger filled in a capsule</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>2 gm of placebo pill (A capsule)</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="116"/>
            <count group_id="B2" value="123"/>
            <count group_id="B3" value="239"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.8" spread="5.3"/>
                    <measurement group_id="B2" value="33.0" spread="4.8"/>
                    <measurement group_id="B3" value="32.9" spread="5.0"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Occurrence of Intra-operative and Post-operative Vomiting</title>
        <description>Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.</description>
        <time_frame>During surgery (1 hour) and thru 72 hours after surgery</time_frame>
        <population>Number of participants who had vomiting in each group is compared to the other group using Chi square test</population>
        <group_list>
          <group group_id="O1">
            <title>Ginger</title>
            <description>2 gm powder of ginger filled in a capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>2 gm of placebo pill (A capsule)</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Intra-operative and Post-operative Vomiting</title>
          <description>Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.</description>
          <population>Number of participants who had vomiting in each group is compared to the other group using Chi square test</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="45"/>
                  </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>
            <groups_desc>Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Considering the null hypothesis that the number of participants who will have vomiting will be equal in the two arms, we performed this study with a significance level of 0.05% and power of 80% to prove that there is a difference in the number.</non_inferiority_desc>
            <p_value>0.07</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Ginger</title>
          <description>2 gm powder of ginger filled in a capsule</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>2 gm of placebo capsule</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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Sandip Darji</name_or_title>
      <organization>New York Methodist Hospital</organization>
      <phone>718/780-3779</phone>
      <email>darji_sandip2005@yahoo.com</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/NCT01733212
org study id: IRB:147810
nct id: NCT01733212
lead sponsor: 
has dmc: Yes
SPECIFIC AIMS

        -  Assess risk factors for nausea and vomiting in c-section patients undergoing regional
           anesthesia

        -  Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in
           the ginger and placebo groups.

        -  Quantify post-operative analgesia and pruritus in the ginger and placebo groups

        -  Quantify patient satisfaction of the ginger and placebo groups

        -  Assess patient expectation of ginger on post-op day three
Two hundred and thirty nine ASA class I and II patients, scheduled for elective c-section
      will be assigned randomly to receive either 1g ginger tablet PO (Group 1) or 1 g placebo PO
      (Group 2) preoperatively, immediately before surgery. The usual preoperative anti-emetic and
      antacid regimen will be continued for both groups. Initial blood pressure, pulse and
      hemoglobin and hematocrit will be documented by the researcher prior to the arrival of the
      patient into the operating room. A baseline questionnaire will be given to the patients to
      assess risk factors for nausea and vomiting. Questions will include: age, BMI, parity, weeks
      gestation, h/o seasickness, h/o of hyperemesis gravidrum in this or prior pregnancies, h/o
      PONV, medical problems, any medication used within past 24 hrs, education and occupation.

      Intraoperatively, both groups will receive combined spinal-epidural anesthesia in the usual
      manner. All standard monitoring will be applied and vital signs recorded for the entirety of
      the procedure. The number and dose of ephedrine or phenylephrine boluses and the number and
      severity of nausea episodes (using a Visual Analog Scale (VANS)) and number of vomiting
      episodes will be noted. In addition the following will be recorded: if uterus was
      exteriorized, any medications used by the anesthesiologist (other than ephedrine and
      phenylephrine), and estimated blood loss.

      Postoperatively, patients will receive either a one time dose of the 1g ginger PO (Group 1)
      or 1 g placebo PO (Group 2) 2 hours after entering the postanesthesia care unit (PACU).
      Thirty minutes after the medication is given, patients will be asked to rate their nausea,
      level of analgesia, and level of pruritus on a VANS, and vomiting episodes will be recorded.
      Medications given for nausea will be continued in the post-operative period for both groups.
      The doses of Zofran will be counted in the 24 hr postoperative period. Twenty-four hours
      after surgery, blood will be drawn to assess hemoglobin and hematocrit as well as to assess
      platelet function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurrence of Intra-operative and Post-operative Vomiting
time frame: During surgery (1 hour) and thru 72 hours after surgery
description: Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.
arm group label: Ginger
arm group type: Experimental
description: 2 gm powder of ginger filled in a capsule
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 gm of placebo pill (A capsule)
intervention type: Drug
intervention name: Ginger
description: Ginger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
arm group label: Ginger
other name: Zingiber Officinale
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Weinberg, MD
role: Principal Investigator
affiliation: New York Presbyterian Brooklyn Methodist Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: New York Presbyterian Brooklyn Methodist Hospital
investigator full name: Joel Yarmush
investigator title: Attending Physician, Program Director (Anesthesiology)
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 