<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/NCT01731756</url>
  </required_header>
  <id_info>
    <org_study_id>BSMMU-003-CT</org_study_id>
    <nct_id>NCT01731756</nct_id>
  </id_info>
  <brief_title>Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis</brief_title>
  <official_title>Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized,&#xD;
      double-blind, placebo-control trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate the effectiveness of topical administration of the&#xD;
      Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of&#xD;
      moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited&#xD;
      on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated&#xD;
      water for more than six months. They will be divided into two groups each will consist of&#xD;
      twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to&#xD;
      apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid&#xD;
      ointment . Water and nail sample will be collected before starting recruitment to confirm&#xD;
      diagnosis. Then again nail sample will be collected before and after the study to see the&#xD;
      level of arsenic in skin. Effects will be observed after every two weeks and change will be&#xD;
      detected as nil, mild reduction, moderate reduction and fully cured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in palmer arsenical keratosis</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>Size and number of keratotic lesions will be reduced. These will be expressed in score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in arsenic level in nail</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Arsenical Keratosis</condition>
  <arm_group>
    <arm_group_label>Palmer arsenical keratosis (study)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Palmer arsenical keratosis (control)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Leaf extract of A. indica</intervention_name>
    <description>Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.</description>
    <arm_group_label>Palmer arsenical keratosis (study)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salicylic Acid (6%)</intervention_name>
    <description>Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.</description>
    <arm_group_label>Palmer arsenical keratosis (control)</arm_group_label>
    <arm_group_label>Palmer arsenical keratosis (study)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Petroleum jelly</intervention_name>
    <description>Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.</description>
    <arm_group_label>Palmer arsenical keratosis (control)</arm_group_label>
    <arm_group_label>Palmer arsenical keratosis (study)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Palmer arsenical keratosis&#xD;
&#xD;
          -  Drinking arsenic contaminated water (&gt;50 ppb) for more than six months&#xD;
&#xD;
          -  Patient voluntarily agree to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lactating mother&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Systemic lupus erythematosus&#xD;
&#xD;
          -  Psoriasis&#xD;
&#xD;
          -  Bowen's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mir Misbahuddin, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>May 2, 2014</last_update_submitted>
  <last_update_submitted_qc>May 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
    <investigator_full_name>Prof. Mir Misbahuddin</investigator_full_name>
    <investigator_title>Prof. and Chairman</investigator_title>
  </responsible_party>
  <keyword>Palm</keyword>
  <keyword>Arsenic</keyword>
  <keyword>Keratosis</keyword>
  <keyword>Salicylic acid</keyword>
  <keyword>Azadirachta indica</keyword>
  <keyword>Neem</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratosis, Actinic</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salicylic Acid</mesh_term>
    <mesh_term>Salicylates</mesh_term>
    <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/NCT01731756
org study id: BSMMU-003-CT
nct id: NCT01731756
lead sponsor: 
has dmc: No
Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized,
      double-blind, placebo-control trial
The objective of this study is to evaluate the effectiveness of topical administration of the
      Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of
      moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited
      on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated
      water for more than six months. They will be divided into two groups each will consist of
      twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to
      apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid
      ointment . Water and nail sample will be collected before starting recruitment to confirm
      diagnosis. Then again nail sample will be collected before and after the study to see the
      level of arsenic in skin. Effects will be observed after every two weeks and change will be
      detected as nil, mild reduction, moderate reduction and fully cured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Changes in palmer arsenical keratosis
time frame: 0 week (baseline), 12 weeks (end)
description: Size and number of keratotic lesions will be reduced. These will be expressed in score.
measure: Changes in arsenic level in nail
time frame: 0 week (baseline), 12 weeks (end)
description: Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.
arm group label: Palmer arsenical keratosis (study)
arm group type: Experimental
description: Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
arm group label: Palmer arsenical keratosis (control)
arm group type: Placebo Comparator
description: Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
intervention type: Other
intervention name: Leaf extract of A. indica
description: Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
arm group label: Palmer arsenical keratosis (study)
intervention type: Drug
intervention name: Salicylic Acid (6%)
description: Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.
arm group label: Palmer arsenical keratosis (control)
arm group label: Palmer arsenical keratosis (study)
intervention type: Other
intervention name: Petroleum jelly
description: Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
arm group label: Palmer arsenical keratosis (control)
arm group label: Palmer arsenical keratosis (study)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mir Misbahuddin, MBBS, PhD
role: Principal Investigator
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
facility: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: Prof. Mir Misbahuddin
investigator title: Prof. and Chairman
mesh term: Keratosis, Actinic
mesh term: Keratosis
mesh term: Salicylic Acid
mesh term: Salicylates
mesh term: Petrolatum