xml: <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/NCT06013254</url>
    </required_header>
    <id_info>
      <org_study_id>TÜTF-BAEK 2021/214</org_study_id>
      <nct_id>NCT06013254</nct_id>
    </id_info>
    <brief_title>Effect of Sour Liquid On Swallowing Function of the Patients With Stroke</brief_title>
    <official_title>Effect of Sour Liquid On Swallowing Function of the Patients With Post-Stroke Dysphagia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Trakya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Trakya 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>
        The aim of this study was to evaluate the effect of early administration of sour liquid on&#xD;
        swallowing function of patients with post-stroke dysphagia.&#xD;
  &#xD;
        Hypothesis of the study were; H0: The sour liquid given early to patients with post-stroke&#xD;
        dysphagia does not have an effect on swallowing function H1: The sour liquid given early to&#xD;
        patients with post-stroke dysphagia has an effect on swallowing function The data of the&#xD;
        study were collected using the &quot;Personal Information Form,&quot; &quot;Standard Swallowing Test,&quot;&#xD;
        &quot;Gagging Swallowing Screening Test (GUSS),&quot; and the &quot; National Institute of Health Stroke&#xD;
        Scale (NIHSS)&quot;.&#xD;
  &#xD;
        Early administration of sour liquid to patients with post-stroke dysphagia was found to have&#xD;
        a positive effect on swallowing function.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Untreated and undetected swallowing disorders lead to increased morbidity and&#xD;
        mortality in acute stroke patients due to inadequate nutrition, dehydration, and aspiration&#xD;
        pneumonia leading to prolonged hospital stays, decreased functionality, and increased&#xD;
        long-term care needs. The aim of this study was to evaluate the effect of early&#xD;
        administration of sour liquid on swallowing function of patients with post-stroke dysphagia.&#xD;
  &#xD;
        Materials and methods: This study was a randomized controlled trial, which was conducted with&#xD;
        95 patients with confirmed diagnosis of ischemic stroke and dysphagia, admitted to the&#xD;
        neurology department of a university hospital. The intervention group (n=47) received 4 ml of&#xD;
        room temperature lemon juice, while the control group (n=48) received 4 ml of room&#xD;
        temperature water before breakfast, lunch, and dinner for a duration of 7 days. The Standard&#xD;
        Swallowing Test, Gagging Swallowing Screen, and National Institutes of Health Stroke Scale&#xD;
        were applied. Swallowing function and stroke severity were assessed at initial assessment, at&#xD;
        the end of the 7th and 30th days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 15, 2021</start_date>
    <completion_date type="Actual">November 20, 2022</completion_date>
    <primary_completion_date type="Actual">July 15, 2022</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>
      <intervention_model_description>Randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>swallowing assessments using the Gugging Swallowing Screen (GUSS) score</measure>
      <time_frame>initial assessment, 7th day assessment, 30th day assessment</time_frame>
      <description>improve the swallowing disorders of patients who have experienced acute stroke through the administration of sour taste. patients in both the intervention and control groups underwent advanced swallowing assessments using the GUSS.&#xD;
  Gugging Swallowing Screen (GUSS)consists of two parts including an indirect swallowing test with three subtests, and a direct swallowing test with four subtests. Evaluation is made on a scale of 0-20 as follows: 0-9 points indicate severe swallowing disorder with high risk of aspiration, 10-14 points indicate moderate swallowing disorder with moderate risk of aspiration, 15-19 points indicate mild swallowing disorder with low risk of aspiration, and 20 points indicate no swallowing disorder.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">95</enrollment>
    <condition>Acute Stroke</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>4 ml of freshly squeezed lemon juice with a pH of 2.8 at room temperature was administered under the supervision of the physician before breakfast, lunch, and dinner for patients with ischemic stroke. For patients with severe swallowing disorders according to the GUSS, lemon juice was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the lemon juice out of their mouths. This procedure was continued for seven days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>4 ml of room temperature water was administered under the supervision of the physician before breakfast, lunch, and dinner. For patients with severe swallowing disorders according to the GUSS, water was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the water out of their mouths. This procedure was continued for seven days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>sour liquid</intervention_name>
      <description>applying lemon juice</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosed with ischemic stroke,&#xD;
  &#xD;
            -  had not completed the first 72 hours after diagnosis,&#xD;
  &#xD;
            -  developed swallowing disorders,&#xD;
  &#xD;
            -  volunteered to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosed hemorrhagic stroke,&#xD;
  &#xD;
            -  had completed the first 72 hours after diagnosis,&#xD;
  &#xD;
            -  not developed swallowing disorders,&#xD;
  &#xD;
            -  not volunteered to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sezgin Kehaya, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Doctor of Neurology Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Trakya University Faculty of Medicine</name>
        <address>
          <city>Edirne</city>
          <zip>22030</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Trakya University</investigator_affiliation>
      <investigator_full_name>Ozgul Erol</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>acute stroke</keyword>
    <keyword>dysphagia</keyword>
    <keyword>swallowing function</keyword>
    <keyword>sour taste</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013254
  org study id: TÜTF-BAEK 2021/214
  nct id: NCT06013254
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to evaluate the effect of early administration of sour liquid on
        swallowing function of patients with post-stroke dysphagia.
  
        Hypothesis of the study were; H0: The sour liquid given early to patients with post-stroke
        dysphagia does not have an effect on swallowing function H1: The sour liquid given early to
        patients with post-stroke dysphagia has an effect on swallowing function The data of the
        study were collected using the "Personal Information Form," "Standard Swallowing Test,"
        "Gagging Swallowing Screening Test (GUSS)," and the " National Institute of Health Stroke
        Scale (NIHSS)".
  
        Early administration of sour liquid to patients with post-stroke dysphagia was found to have
        a positive effect on swallowing function.
  Background: Untreated and undetected swallowing disorders lead to increased morbidity and
        mortality in acute stroke patients due to inadequate nutrition, dehydration, and aspiration
        pneumonia leading to prolonged hospital stays, decreased functionality, and increased
        long-term care needs. The aim of this study was to evaluate the effect of early
        administration of sour liquid on swallowing function of patients with post-stroke dysphagia.
  
        Materials and methods: This study was a randomized controlled trial, which was conducted with
        95 patients with confirmed diagnosis of ischemic stroke and dysphagia, admitted to the
        neurology department of a university hospital. The intervention group (n=47) received 4 ml of
        room temperature lemon juice, while the control group (n=48) received 4 ml of room
        temperature water before breakfast, lunch, and dinner for a duration of 7 days. The Standard
        Swallowing Test, Gagging Swallowing Screen, and National Institutes of Health Stroke Scale
        were applied. Swallowing function and stroke severity were assessed at initial assessment, at
        the end of the 7th and 30th days.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: swallowing assessments using the Gugging Swallowing Screen (GUSS) score
  time frame: initial assessment, 7th day assessment, 30th day assessment
  description: improve the swallowing disorders of patients who have experienced acute stroke through the administration of sour taste. patients in both the intervention and control groups underwent advanced swallowing assessments using the GUSS.
  Gugging Swallowing Screen (GUSS)consists of two parts including an indirect swallowing test with three subtests, and a direct swallowing test with four subtests. Evaluation is made on a scale of 0-20 as follows: 0-9 points indicate severe swallowing disorder with high risk of aspiration, 10-14 points indicate moderate swallowing disorder with moderate risk of aspiration, 15-19 points indicate mild swallowing disorder with low risk of aspiration, and 20 points indicate no swallowing disorder.
  arm group label: Intervention group
  arm group type: Experimental
  description: 4 ml of freshly squeezed lemon juice with a pH of 2.8 at room temperature was administered under the supervision of the physician before breakfast, lunch, and dinner for patients with ischemic stroke. For patients with severe swallowing disorders according to the GUSS, lemon juice was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the lemon juice out of their mouths. This procedure was continued for seven days.
  arm group label: Control group
  arm group type: No Intervention
  description: 4 ml of room temperature water was administered under the supervision of the physician before breakfast, lunch, and dinner. For patients with severe swallowing disorders according to the GUSS, water was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the water out of their mouths. This procedure was continued for seven days.
  intervention type: Dietary Supplement
  intervention name: sour liquid
  description: applying lemon juice
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sezgin Kehaya, MD
  role: Principal Investigator
  affiliation: Doctor of Neurology Clinic
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Trakya University
  investigator full name: Ozgul Erol
  investigator title: Professor
  mesh term: Stroke