<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/NCT03815305</url>
  </required_header>
  <id_info>
    <org_study_id>441/UN2.F1/ETIK/2018/</org_study_id>
    <nct_id>NCT03815305</nct_id>
  </id_info>
  <brief_title>Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2</brief_title>
  <official_title>Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2: a Study on N(6)-Carboxymethyl-lysine, Interleukin 1-α, Dan Superoxide Dismutase in Stratum Corneum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia 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 objective of this study is to evaluate the effect of Centella asiatica on hydration&#xD;
      status of lower leg skin of DM type 2 patients by measuring SRRC and Skin Capacitance in&#xD;
      correlation with AGEs CML, inflammation marker IL-1α, and oxidative stress SOD in stratum&#xD;
      corneum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This ia a double blind randomized clinical trial on patients diagnosed with DM type 2 with&#xD;
      dry skin to assess the effect of Centella asiatica (CA) on dry skin in corellation with AGEs&#xD;
      CML, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum after four weeks&#xD;
      of treatment. Subjects are divided into three groups of treatment. The first group treated&#xD;
      with oral CA and topical CA, second group treated with oral placebo and topical CA, and the&#xD;
      last group treated with oral and topical placebo. The total subjects in each treatment groups&#xD;
      are 53 subjects. The recruited subjects will be randomized to receive three different&#xD;
      treatments, consist of 1. First group (A) will receive combination of oral CA at 2x1100 mg&#xD;
      dose and 1% topical CA ointment. 2. Second group (B) will receive oral placebo and topical CA&#xD;
      1% ointment 3. Third group (C) will receive oral placebo and petroleum jelly as topical&#xD;
      placebo The recruited subjects will still receive the prescribed treatment for DM type 2. The&#xD;
      treatment for dry skin will be administered for 28 days. Randomization done by our supervisor&#xD;
      using computer program (RandlistR) by assigning code number for each subjects. The procedures&#xD;
      of treatment administration are explained below: 1. Every subject will receive 56 capsules&#xD;
      and 10 gram of ointment to be used in 2 weeks period. Subjects will also receive explanation&#xD;
      on how to take the drugs 2. Oral drug are taken 2 capsules (@ 550 mg) b.i.d over 12 hours. 3.&#xD;
      The ointment is applied two times a day 15 minutes after bath time. 4. The application have&#xD;
      to be distributed evenly on a specific 7 x 20 cms area on lower leg. All patients will be&#xD;
      given plastic cover to determine the area. 5. The estimation of ointment applied on every leg&#xD;
      is as much as ½ FTU or about 0,25 gram. 6. After 2 week period ended, subject will be given&#xD;
      the same treatment at follow-up visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 30, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 12, 2019</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Skin Capacitance</measure>
    <time_frame>1 month (evaluated every 2 weeks)</time_frame>
    <description>SCap measured in (AU)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in SOD</measure>
    <time_frame>1 month (evaluated every 2 weeks)</time_frame>
    <description>Superoxide Dismutase (compared to total protein)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in IL-1α</measure>
    <time_frame>1 month (evaluated every 2 weeks)</time_frame>
    <description>Interleukin-1α (compared to total protein)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in AGEs CML</measure>
    <time_frame>1 month (evaluated every 2 week)</time_frame>
    <description>Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in SRRC</measure>
    <time_frame>1 month (evaluated every 2 week)</time_frame>
    <description>Specified symptom sum score. Measuring dry skin using four variables (scale, roughness, redness, and cracking) in score ranged from 1 to 4 for each variable. The highest the value marks the driest skin</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Xerosis Cutis</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Topical CA and Placebo Oral Drug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient given 10gr 1% CA ointment and 56 pcs of placebo drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Petroleum Jelly and placebo oral drug</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient given 10gr petroleum jelly 100% topical ointment and 56 pcs of placebo drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Centella asiatica extract and Topical CA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient given 10gr 1% CA ointment and 56 pcs of drug containing CA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Centella Asiatica Extract</intervention_name>
    <description>centlla asiatica oral drug at 1100 mg dose</description>
    <arm_group_label>Centella asiatica extract and Topical CA</arm_group_label>
    <other_name>Oral CA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical CA</intervention_name>
    <description>1% centella asiatica ointment</description>
    <arm_group_label>Topical CA and Placebo Oral Drug</arm_group_label>
    <other_name>Centella asiatica ointment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Petroleum jelly</intervention_name>
    <description>vaseline album</description>
    <arm_group_label>Petroleum Jelly and placebo oral drug</arm_group_label>
    <other_name>Topical Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Diabetes Mellitus Type 2&#xD;
&#xD;
          -  &lt;60 years old by the end of the study&#xD;
&#xD;
          -  suffered from dry skin on lower leg skin area, (minimum score= 3, measured using SRRC)&#xD;
&#xD;
          -  agree to not use any skin care product orally or topically on lower leg skin and any&#xD;
             other drugs (unless its part of diabetes mellitus management)&#xD;
&#xD;
          -  normal ankle brachial index value ranged from 0.91-1.3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of diabetic ulcer on one of patient's foot&#xD;
&#xD;
          -  the presence of infection or dermatitis on the experimented foot&#xD;
&#xD;
          -  the presence of severe inflammation on the experimented skin (redness score &gt;2 or/and&#xD;
             fissure score &gt;2 measured by SRRC or/and total SRRC score ranged from12-16)&#xD;
&#xD;
          -  estimated glomerular filtration rate value (eGFR) &lt; 45&#xD;
&#xD;
          -  impaired liver function (increased by 2x from upper limit reference for AST/ALT)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suhendro Suhendro, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Indonesia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitas Indonesia</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Dr. Lili Legiawati, SpKK(K)</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>dry skin</keyword>
  <keyword>dm type 2</keyword>
  <keyword>centella asiatica</keyword>
  <keyword>superoxide dismutase</keyword>
  <keyword>AGEs CML</keyword>
  <keyword>IL-1α</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Petrolatum</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03815305
org study id: 441/UN2.F1/ETIK/2018/
nct id: NCT03815305
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the effect of Centella asiatica on hydration
      status of lower leg skin of DM type 2 patients by measuring SRRC and Skin Capacitance in
      correlation with AGEs CML, inflammation marker IL-1α, and oxidative stress SOD in stratum
      corneum.
This ia a double blind randomized clinical trial on patients diagnosed with DM type 2 with
      dry skin to assess the effect of Centella asiatica (CA) on dry skin in corellation with AGEs
      CML, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum after four weeks
      of treatment. Subjects are divided into three groups of treatment. The first group treated
      with oral CA and topical CA, second group treated with oral placebo and topical CA, and the
      last group treated with oral and topical placebo. The total subjects in each treatment groups
      are 53 subjects. The recruited subjects will be randomized to receive three different
      treatments, consist of 1. First group (A) will receive combination of oral CA at 2x1100 mg
      dose and 1% topical CA ointment. 2. Second group (B) will receive oral placebo and topical CA
      1% ointment 3. Third group (C) will receive oral placebo and petroleum jelly as topical
      placebo The recruited subjects will still receive the prescribed treatment for DM type 2. The
      treatment for dry skin will be administered for 28 days. Randomization done by our supervisor
      using computer program (RandlistR) by assigning code number for each subjects. The procedures
      of treatment administration are explained below: 1. Every subject will receive 56 capsules
      and 10 gram of ointment to be used in 2 weeks period. Subjects will also receive explanation
      on how to take the drugs 2. Oral drug are taken 2 capsules (@ 550 mg) b.i.d over 12 hours. 3.
      The ointment is applied two times a day 15 minutes after bath time. 4. The application have
      to be distributed evenly on a specific 7 x 20 cms area on lower leg. All patients will be
      given plastic cover to determine the area. 5. The estimation of ointment applied on every leg
      is as much as ½ FTU or about 0,25 gram. 6. After 2 week period ended, subject will be given
      the same treatment at follow-up visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Skin Capacitance
time frame: 1 month (evaluated every 2 weeks)
description: SCap measured in (AU)
measure: Change in SOD
time frame: 1 month (evaluated every 2 weeks)
description: Superoxide Dismutase (compared to total protein)
measure: Change in IL-1α
time frame: 1 month (evaluated every 2 weeks)
description: Interleukin-1α (compared to total protein)
measure: Change in AGEs CML
time frame: 1 month (evaluated every 2 week)
description: Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein)
measure: Change in SRRC
time frame: 1 month (evaluated every 2 week)
description: Specified symptom sum score. Measuring dry skin using four variables (scale, roughness, redness, and cracking) in score ranged from 1 to 4 for each variable. The highest the value marks the driest skin
arm group label: Topical CA and Placebo Oral Drug
arm group type: Active Comparator
description: Patient given 10gr 1% CA ointment and 56 pcs of placebo drug
arm group label: Petroleum Jelly and placebo oral drug
arm group type: Placebo Comparator
description: Patient given 10gr petroleum jelly 100% topical ointment and 56 pcs of placebo drug
arm group label: Centella asiatica extract and Topical CA
arm group type: Experimental
description: Patient given 10gr 1% CA ointment and 56 pcs of drug containing CA
intervention type: Drug
intervention name: Centella Asiatica Extract
description: centlla asiatica oral drug at 1100 mg dose
arm group label: Centella asiatica extract and Topical CA
other name: Oral CA
intervention type: Drug
intervention name: Topical CA
description: 1% centella asiatica ointment
arm group label: Topical CA and Placebo Oral Drug
other name: Centella asiatica ointment
intervention type: Drug
intervention name: Petroleum jelly
description: vaseline album
arm group label: Petroleum Jelly and placebo oral drug
other name: Topical Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: 60 Years
healthy volunteers: No
last name: Suhendro Suhendro, Doctor
role: Study Chair
affiliation: Indonesia University
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Dr. Lili Legiawati, SpKK(K)
investigator title: Principle Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Petrolatum