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/NCT06013202</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU-RecID032111</org_study_id>
      <nct_id>NCT06013202</nct_id>
    </id_info>
    <brief_title>The Efficacy of Nigella Sativa Oil Mouth Rinse in the Management of Recurrent Minor Aphthous Ulcer</brief_title>
    <official_title>The Efficacy of Nigella Sativa Oil Mouth Rinse in the Management of Recurrent Minor Aphthous Ulcer A Randomized Controlled Clinical Trial With Biochemical Analysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nada Sherif</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ain Shams 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>
        This research aims to investigate the effectiveness of Nigella Sativa Oil Mouth Rinse&#xD;
        application both clinically and biochemically as a suitable affordable treatment modality for&#xD;
        Management of Recurrent Minor Aphthous Ulcer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Twenty patients will be selected from the outpatient clinic of the department of Oral&#xD;
        Medicine, Periodontology, and Oral diagnosis, Faculty of Dentistry, Ain Shams University and&#xD;
        will be divided into two groups (test group and control group), 10 in each group. Ten&#xD;
        patients will receive Nigella Sativa oil mouth rinse. Ten patients will receive the placebo&#xD;
        isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl). At the screening&#xD;
        visit, patient history will be documented, and subjects who met the inclusion/exclusion&#xD;
        criteria were asked to complete the survey to determine the severity of their symptoms prior&#xD;
        to clinical examination. The oral examination will be a routine visual assessment to document&#xD;
        the presence, location and size of an ulcerative oral mucosal lesion.&#xD;
  &#xD;
        Patients will be asked to use the NS oil mouth rinse (10 ml each 6 hrs.) four times daily.&#xD;
        Subjects will be provided with 72 hours supply of the study product.&#xD;
  &#xD;
        Patients will be instructed to use it for 72 hours with a minimum frequency of four times per&#xD;
        day, swished for one minute at each use, in which the first dose was used upon awakening and&#xD;
        the last dose just before evening sleep. Patients will be instructed not to use over the&#xD;
        counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.&#xD;
        The same procedure will be done in the control group but by using isotonic (normal saline)&#xD;
        with concentration 0.90% of sodium chloride (NaCl). The patients will be re-examined after&#xD;
        24, 48, 72 hrs. from the beginning of the treatment until the complete healing of the (RAU).&#xD;
        When patients completed the follow-up phase after product use, they will be asked to repeat&#xD;
        the surveys in which they documented the pain scores and oral symptoms. The ulcer size will&#xD;
        be measured using periodontal calibrated probe before treatment and after 24, 48, 72 hrs. of&#xD;
        treatment until the complete healing of the (RAU).Clinical photographs of the ulcers will be&#xD;
        taken using a digital camera preoperatively and after 24, 48, 72 hrs. of treatment until the&#xD;
        complete healing of the (RAU). Patients of discomfort and pain severity will be rated at&#xD;
        baseline, 24, 48, 72 hours and day seven after using the study product by numeric rating&#xD;
        scale (NRS) and visual analog scale for pain (VAS) since, the association between NRS and VAS&#xD;
        would be stronger.&#xD;
  &#xD;
        The salivary TNF-α levels in RAS patients can be detected by using saliva as a convenient&#xD;
        medium and it will be measured prior to the definitive therapy and at the end of using the&#xD;
        study product. Distilled water was given to the patients to rinse their oral cavity for 1&#xD;
        minute to remove any debris. Under aseptic conditions, a minimum of 2 ml of saliva will be&#xD;
        collected from the patient through 'Spit Technique' after oral rinse with water at room&#xD;
        temperature into sterilized tubes every minute for 8-10 minutes. The saliva samples will be&#xD;
        collected after one hour or more since the last food intake. The patients will be asked to&#xD;
        avoid drinking one hour before sampling. Samples will be immediately frozen at -20°C .The&#xD;
        estimation salivary contents of TNF-α will done by enzyme linked immunosorbent assay using a&#xD;
        commercial ready-made ELISA kit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 22, 2023</start_date>
    <completion_date type="Anticipated">September 22, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 12, 2024</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>This study is designed as a parallel randomized control clinical trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>management of recurrent minor aphthous ulcer as well as patient satisfaction.</measure>
      <time_frame>2 week from the baselline</time_frame>
      <description>At the screening visit the discomfort and pain severity of patient's symptoms prior to clinical examination will be rated at baseline, Subjects will be provided with 72 hours supply of the study product. The patients will be re-examined after 24, 48, 72 hrs. and day seven ( a week ) from the beginning of the treatment until the complete healing of the recurrent minor aphthous ulcer which estimated by two week from the baseline. All patients should be with Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluate the effect of Nigella Sativa oil mouth rinse biochemically on the salivary TNF-α level.</measure>
      <time_frame>2 week from the baselline</time_frame>
      <description>The salivary TNF-α levels in recurrent minor aphthous ulcer patients will be detected by using saliva as a convenient medium, Salivary samples will be collected at baseline before the intervention and after 24, 48, 72 hrs. and day seven ( a week ) from the beginning of the treatment until the complete healing of the recurrent minor aphthous ulcer which estimated by two week from the baseline</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Aphthous Ulcer</condition>
    <arm_group>
      <arm_group_label>Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ten patients will receive Nigella Sativa oil mouth rinse. Patients will be asked to use the NS oil mouth rinse (10 ml each 6 hrs.) four times daily . Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (CONTROL GROUP)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Ten patients will receive the placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl). Patients will be asked to use it as mouth rinse (10 ml each 6 hrs.) four times daily . Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nigella Sativa Oil Mouth Rinse</intervention_name>
      <description>Nigella Sativa Oil Mouth Rinse</description>
      <arm_group_label>Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)</intervention_name>
      <description>isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)</description>
      <arm_group_label>Group 2 (CONTROL GROUP)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients should be free from any systemic disease or Behcet syndrome (Atai et al.,&#xD;
               2007).&#xD;
  &#xD;
            -  Patients male or female are eligible (Epstein et al., 2018).&#xD;
  &#xD;
            -  Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the&#xD;
               presence of oral ulceration (Epstein et al., 2018).&#xD;
  &#xD;
            -  Patient has only minor aphthous ulcer and its diameter should be less than 1 cm (Atai&#xD;
               et al., 2007).&#xD;
  &#xD;
            -  It should had not been passed more than 4 days from beginning of their ulcer (Atai et&#xD;
               al., 2007).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with poor oral hygiene or not willing to perform oral hygiene measures.&#xD;
  &#xD;
            -  Smoking and alcohol use.&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  Patients with history of any topical or systemic medication or steroid therapy 1 month&#xD;
               prior to the investigation (Chaudhuri et al., 2018).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nevine Hassan Kheir El Din, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmed Elsayed Hamed Amr, Lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Olfat Gameel Shaker, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nada Sherif</last_name>
      <phone>01011922306</phone>
      <email>nadasherif33@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nada Mohamed Sherif Aly abdelhamid</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>nada sherif, PHD</last_name>
        <phone>01011922306</phone>
        <email>nadasherif33@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 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 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Nada Sherif</investigator_full_name>
      <investigator_title>Principal Investiagator</investigator_title>
    </responsible_party>
    <keyword>recurrent</keyword>
    <keyword>aphthous ulcer</keyword>
    <keyword>minor</keyword>
    <keyword>nigella sativa</keyword>
    <keyword>mouth rinse</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomatitis, Aphthous</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06013202
  org study id: FDASU-RecID032111
  nct id: NCT06013202
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This research aims to investigate the effectiveness of Nigella Sativa Oil Mouth Rinse
        application both clinically and biochemically as a suitable affordable treatment modality for
        Management of Recurrent Minor Aphthous Ulcer
  Twenty patients will be selected from the outpatient clinic of the department of Oral
        Medicine, Periodontology, and Oral diagnosis, Faculty of Dentistry, Ain Shams University and
        will be divided into two groups (test group and control group), 10 in each group. Ten
        patients will receive Nigella Sativa oil mouth rinse. Ten patients will receive the placebo
        isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl). At the screening
        visit, patient history will be documented, and subjects who met the inclusion/exclusion
        criteria were asked to complete the survey to determine the severity of their symptoms prior
        to clinical examination. The oral examination will be a routine visual assessment to document
        the presence, location and size of an ulcerative oral mucosal lesion.
  
        Patients will be asked to use the NS oil mouth rinse (10 ml each 6 hrs.) four times daily.
        Subjects will be provided with 72 hours supply of the study product.
  
        Patients will be instructed to use it for 72 hours with a minimum frequency of four times per
        day, swished for one minute at each use, in which the first dose was used upon awakening and
        the last dose just before evening sleep. Patients will be instructed not to use over the
        counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.
        The same procedure will be done in the control group but by using isotonic (normal saline)
        with concentration 0.90% of sodium chloride (NaCl). The patients will be re-examined after
        24, 48, 72 hrs. from the beginning of the treatment until the complete healing of the (RAU).
        When patients completed the follow-up phase after product use, they will be asked to repeat
        the surveys in which they documented the pain scores and oral symptoms. The ulcer size will
        be measured using periodontal calibrated probe before treatment and after 24, 48, 72 hrs. of
        treatment until the complete healing of the (RAU).Clinical photographs of the ulcers will be
        taken using a digital camera preoperatively and after 24, 48, 72 hrs. of treatment until the
        complete healing of the (RAU). Patients of discomfort and pain severity will be rated at
        baseline, 24, 48, 72 hours and day seven after using the study product by numeric rating
        scale (NRS) and visual analog scale for pain (VAS) since, the association between NRS and VAS
        would be stronger.
  
        The salivary TNF-α levels in RAS patients can be detected by using saliva as a convenient
        medium and it will be measured prior to the definitive therapy and at the end of using the
        study product. Distilled water was given to the patients to rinse their oral cavity for 1
        minute to remove any debris. Under aseptic conditions, a minimum of 2 ml of saliva will be
        collected from the patient through 'Spit Technique' after oral rinse with water at room
        temperature into sterilized tubes every minute for 8-10 minutes. The saliva samples will be
        collected after one hour or more since the last food intake. The patients will be asked to
        avoid drinking one hour before sampling. Samples will be immediately frozen at -20°C .The
        estimation salivary contents of TNF-α will done by enzyme linked immunosorbent assay using a
        commercial ready-made ELISA kit.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is designed as a parallel randomized control clinical trial
  primary purpose: Other
  masking: Single (Participant)
  masking description: single
  measure: management of recurrent minor aphthous ulcer as well as patient satisfaction.
  time frame: 2 week from the baselline
  description: At the screening visit the discomfort and pain severity of patient's symptoms prior to clinical examination will be rated at baseline, Subjects will be provided with 72 hours supply of the study product. The patients will be re-examined after 24, 48, 72 hrs. and day seven ( a week ) from the beginning of the treatment until the complete healing of the recurrent minor aphthous ulcer which estimated by two week from the baseline. All patients should be with Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration
  measure: Evaluate the effect of Nigella Sativa oil mouth rinse biochemically on the salivary TNF-α level.
  time frame: 2 week from the baselline
  description: The salivary TNF-α levels in recurrent minor aphthous ulcer patients will be detected by using saliva as a convenient medium, Salivary samples will be collected at baseline before the intervention and after 24, 48, 72 hrs. and day seven ( a week ) from the beginning of the treatment until the complete healing of the recurrent minor aphthous ulcer which estimated by two week from the baseline
  arm group label: Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse
  arm group type: Experimental
  description: Ten patients will receive Nigella Sativa oil mouth rinse. Patients will be asked to use the NS oil mouth rinse (10 ml each 6 hrs.) four times daily . Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.
  arm group label: Group 2 (CONTROL GROUP)
  arm group type: Active Comparator
  description: Ten patients will receive the placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl). Patients will be asked to use it as mouth rinse (10 ml each 6 hrs.) four times daily . Subjects will be provided with 72 hours supply of the study product. Patients will be instructed to use it for 72 hours with a minimum frequency of four times per day, swished for one minute at each use, in which the first dose was used upon awakening and the last dose just before evening sleep. Patients will be instructed not to use over the counter (OTC) or pharmacy formulated oral rinses or gels during the active treatment phase.
  intervention type: Other
  intervention name: Nigella Sativa Oil Mouth Rinse
  description: Nigella Sativa Oil Mouth Rinse
  arm group label: Group 1 (TEST GROUP) Nigella Sativa oil mouth rinse
  intervention type: Other
  intervention name: isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)
  description: isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl)
  arm group label: Group 2 (CONTROL GROUP)
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nevine Hassan Kheir El Din, Professor
  role: Study Director
  affiliation: Ain Shams University
  last name: Ahmed Elsayed Hamed Amr, Lecturer
  role: Study Director
  affiliation: Ain Shams University
  last name: Olfat Gameel Shaker, Professor
  role: Study Director
  affiliation: Ain Shams University
  last name: Nada Sherif
  phone: 01011922306
  email: nadasherif33@yahoo.com
  facility: 
  contact: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Nada Sherif
  investigator title: Principal Investiagator
  mesh term: Stomatitis, Aphthous
  mesh term: Ulcer
  sharing ipd: No