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/NCT06039774</url>
    </required_header>
    <id_info>
      <org_study_id>Pharm-202309.01</org_study_id>
      <nct_id>NCT06039774</nct_id>
    </id_info>
    <brief_title>α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS)</brief_title>
    <acronym>AM-RAS</acronym>
    <official_title>Clinical Efficacy of α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS) Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitas Padjadjaran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitas Padjadjaran</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>
        Recurrent Aphthous Stomatitis (RAS) is experienced by almost everyone and appears suddenly.&#xD;
        Even though the risk of death due to the condition is small, its presence can make a person&#xD;
        feel uncomfortable eating, drinking, and talking so there will be a decrease in the quality&#xD;
        of a person's life in their daily lives. Recently, α-Mangostin (α-M) from mangosteen rind&#xD;
        (Garcinia mangostana L) has been shown its effect to reduce oral mucosal sores on RAS in&#xD;
        preclinical studies in rats. Therefore, research is needed to prove the benefits (efficacy)&#xD;
        and safety of therapy in the form of a hydrogel film patch/plaster film with a chitosan&#xD;
        alginate base as a carrier for α-Mangostin for the treatment of RAS patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Topical medications are the primary option for addressing RAS (Recurrent Aphthous Stomatitis)&#xD;
        due to their affordability, effectiveness, and safety. These treatments encompass various&#xD;
        forms such as mouthwashes, aerosols, lozenges, and ointments, available in liquid, solid, and&#xD;
        semi-solid preparations. However, employing topical drugs faces challenges related to&#xD;
        achieving desired therapeutic outcomes. A significant hurdle is the hindered delivery of&#xD;
        drugs to the oral mucosa, often referred to as &quot;saliva wash out,&quot; which leads to the removal&#xD;
        and rinsing away of the drug from the mucosal surface.&#xD;
  &#xD;
        Efforts in developing drug delivery systems for RAS treatment are directed towards achieving&#xD;
        several goals. These include prolonging the time drugs remain effective at the site of the&#xD;
        ulcer, ensuring the release of adequate drug concentrations to the ulcer, and alleviating&#xD;
        pain. Addressing this issue involves the creation of film formulations that can serve as a&#xD;
        protective layer for the ulcer. Such formulations act as barriers against external stimuli&#xD;
        while offering a certain degree of pain relief.&#xD;
  &#xD;
        An indigenous plant of Indonesia that has found application in traditional healing is the&#xD;
        mangostin peel (Garcinia mangostana L.). α-mangostin, extracted from the rind of the&#xD;
        mangosteen, has been employed in traditional medicine. Among its attributes, α-mangostin&#xD;
        exhibits anti-inflammatory properties, functioning effectively by impeding the inflammatory&#xD;
        response. This characteristic positions α-mangostin as a viable alternative compound for&#xD;
        addressing RAS management. To facilitate the delivery of α-mangostin, a combination of two&#xD;
        mucoadhesive polymers, specifically sodium alginate and chitosan, is utilized as a drug&#xD;
        delivery system.&#xD;
  &#xD;
        In earlier studies, the development and analysis of a hydrogel film containing α-mangostin,&#xD;
        utilizing a chitosan-alginate foundation, were conducted to explore their potential for&#xD;
        treating RAS in vivo. These experiments involved testing on white Wistar rats, resulting in a&#xD;
        remarkable 93% healing rate by the seventh day. Consequently, additional research focusing on&#xD;
        the chitosan-alginate based α-mangostin hydrogel film will progress to clinical and safety&#xD;
        trials. The objective is to establish its effectiveness among RAS patients and assess its&#xD;
        suitability as a readily applicable treatment option.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">March 12, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 22, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Ulcer Size</measure>
      <time_frame>7 days</time_frame>
      <description>The diameter of the ulcer will be measured twice (day 1 and day 7) using a ruler.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain Visual Analogue Scale (VAS Score)</measure>
      <time_frame>7 days</time_frame>
      <description>Determine the effect of α-Mangostin for reducing pain intensity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (the worst pain ever felt / imagined by the subject). After being explained, subjects will be asked to place a mark on the line to rate their current level of pain. The investigators will measure the distance of the mark from 0 end point using a ruler and record the number up to 1 decimal point.&#xD;
  VAS scores will be measured and recorded twice, i.e. day 1 and day 7.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Recurrent Aphthous Stomatitis</condition>
    <arm_group>
      <arm_group_label>α-Mangostin Hydrogel Film With Chitosan Alginate Base</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive α-Mangostin Hydrogel Film With Chitosan Alginate Base in the form of a patch. Subjects will apply the patch once a day after breakfast or at night before sleep, subjects will be told to avoid drinking or eating for 1 hour after using the hydrogel film because these activities can remove the hydrogel film. Ulcer size and VAS score will recorded on the first day (baseline), the 3rd day, the 5th day, and the 7th day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Subjects will receive Hydrogel Film With Chitosan Alginate Base without an active compound in the form of a patch. Subjects will apply the patch once a day after breakfast or at night before sleep and will be told to avoid drinking or eating for 1 hour after using the hydrogel film because these activities can remove the hydrogel film. Ulcer size and VAS score will recorded on the first day (baseline), the 3rd day, the 5th day, and the 7th day</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>α-Mangostin Hydrogel Film With Chitosan Alginate Base</intervention_name>
      <description>Patients will apply α-Mangostin Hydrogel Film With Chitosan Alginate Base once a day for 7 days</description>
      <arm_group_label>α-Mangostin Hydrogel Film With Chitosan Alginate Base</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-40 years&#xD;
  &#xD;
            -  Healthy subjects without mouth diseases&#xD;
  &#xD;
            -  Not using drugs for RAS therapy&#xD;
  &#xD;
            -  Not involved with other clinical trials&#xD;
  &#xD;
            -  Willing to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have a mouth disease&#xD;
  &#xD;
            -  Have other serious illnesses, including arrhythmia, uncontrolled hypertension,&#xD;
               diabetes, hepatitis, and kidney failure&#xD;
  &#xD;
            -  pregnant or lactating women, and women who wish to become pregnant during the study&#xD;
               period&#xD;
  &#xD;
            -  poor oral hygiene that requires treatment&#xD;
  &#xD;
            -  chronic diseases requiring treatment with antibiotics, hormones, nonsteroidal&#xD;
               anti-inflammatory drugs, immunosuppressants, immune enhancers, cytotoxic drugs, or&#xD;
               cell cycle agents that affect the oral mucosa&#xD;
  &#xD;
            -  mental illness or limited mental capacities&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Indah Suasani Wahyuni, drg.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Dentistry Universitas Padjadjaran Bandung</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cszahreyloren Vitamia, M.Si</last_name>
      <phone>+6282120176639</phone>
      <email>cszahreyloren20001@mail.unpad.ac.id</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nasrul Wathoni, Ph.D</last_name>
      <phone>+6281313142421</phone>
      <email>nasrul@unpad.ac.id</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomatitis</mesh_term>
      <mesh_term>Stomatitis, Aphthous</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chitosan</mesh_term>
    </intervention_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/NCT06039774
  org study id: Pharm-202309.01
  nct id: NCT06039774
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Recurrent Aphthous Stomatitis (RAS) is experienced by almost everyone and appears suddenly.
        Even though the risk of death due to the condition is small, its presence can make a person
        feel uncomfortable eating, drinking, and talking so there will be a decrease in the quality
        of a person's life in their daily lives. Recently, α-Mangostin (α-M) from mangosteen rind
        (Garcinia mangostana L) has been shown its effect to reduce oral mucosal sores on RAS in
        preclinical studies in rats. Therefore, research is needed to prove the benefits (efficacy)
        and safety of therapy in the form of a hydrogel film patch/plaster film with a chitosan
        alginate base as a carrier for α-Mangostin for the treatment of RAS patients.
  Topical medications are the primary option for addressing RAS (Recurrent Aphthous Stomatitis)
        due to their affordability, effectiveness, and safety. These treatments encompass various
        forms such as mouthwashes, aerosols, lozenges, and ointments, available in liquid, solid, and
        semi-solid preparations. However, employing topical drugs faces challenges related to
        achieving desired therapeutic outcomes. A significant hurdle is the hindered delivery of
        drugs to the oral mucosa, often referred to as "saliva wash out," which leads to the removal
        and rinsing away of the drug from the mucosal surface.
  
        Efforts in developing drug delivery systems for RAS treatment are directed towards achieving
        several goals. These include prolonging the time drugs remain effective at the site of the
        ulcer, ensuring the release of adequate drug concentrations to the ulcer, and alleviating
        pain. Addressing this issue involves the creation of film formulations that can serve as a
        protective layer for the ulcer. Such formulations act as barriers against external stimuli
        while offering a certain degree of pain relief.
  
        An indigenous plant of Indonesia that has found application in traditional healing is the
        mangostin peel (Garcinia mangostana L.). α-mangostin, extracted from the rind of the
        mangosteen, has been employed in traditional medicine. Among its attributes, α-mangostin
        exhibits anti-inflammatory properties, functioning effectively by impeding the inflammatory
        response. This characteristic positions α-mangostin as a viable alternative compound for
        addressing RAS management. To facilitate the delivery of α-mangostin, a combination of two
        mucoadhesive polymers, specifically sodium alginate and chitosan, is utilized as a drug
        delivery system.
  
        In earlier studies, the development and analysis of a hydrogel film containing α-mangostin,
        utilizing a chitosan-alginate foundation, were conducted to explore their potential for
        treating RAS in vivo. These experiments involved testing on white Wistar rats, resulting in a
        remarkable 93% healing rate by the seventh day. Consequently, additional research focusing on
        the chitosan-alginate based α-mangostin hydrogel film will progress to clinical and safety
        trials. The objective is to establish its effectiveness among RAS patients and assess its
        suitability as a readily applicable treatment option.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Ulcer Size
  time frame: 7 days
  description: The diameter of the ulcer will be measured twice (day 1 and day 7) using a ruler.
  measure: Pain Visual Analogue Scale (VAS Score)
  time frame: 7 days
  description: Determine the effect of α-Mangostin for reducing pain intensity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (the worst pain ever felt / imagined by the subject). After being explained, subjects will be asked to place a mark on the line to rate their current level of pain. The investigators will measure the distance of the mark from 0 end point using a ruler and record the number up to 1 decimal point.
  VAS scores will be measured and recorded twice, i.e. day 1 and day 7.
  arm group label: α-Mangostin Hydrogel Film With Chitosan Alginate Base
  arm group type: Experimental
  description: Subjects will receive α-Mangostin Hydrogel Film With Chitosan Alginate Base in the form of a patch. Subjects will apply the patch once a day after breakfast or at night before sleep, subjects will be told to avoid drinking or eating for 1 hour after using the hydrogel film because these activities can remove the hydrogel film. Ulcer size and VAS score will recorded on the first day (baseline), the 3rd day, the 5th day, and the 7th day
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Subjects will receive Hydrogel Film With Chitosan Alginate Base without an active compound in the form of a patch. Subjects will apply the patch once a day after breakfast or at night before sleep and will be told to avoid drinking or eating for 1 hour after using the hydrogel film because these activities can remove the hydrogel film. Ulcer size and VAS score will recorded on the first day (baseline), the 3rd day, the 5th day, and the 7th day
  intervention type: Drug
  intervention name: α-Mangostin Hydrogel Film With Chitosan Alginate Base
  description: Patients will apply α-Mangostin Hydrogel Film With Chitosan Alginate Base once a day for 7 days
  arm group label: α-Mangostin Hydrogel Film With Chitosan Alginate Base
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Indah Suasani Wahyuni, drg.
  role: Principal Investigator
  affiliation: Faculty of Dentistry Universitas Padjadjaran Bandung
  last name: Cszahreyloren Vitamia, M.Si
  phone: +6282120176639
  email: cszahreyloren20001@mail.unpad.ac.id
  last name: Nasrul Wathoni, Ph.D
  phone: +6281313142421
  email: nasrul@unpad.ac.id
  responsible party type: Sponsor
  mesh term: Stomatitis
  mesh term: Stomatitis, Aphthous
  mesh term: Recurrence
  mesh term: Chitosan