<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/NCT01735097</url>
  </required_header>
  <id_info>
    <org_study_id>BSMMU-002-CT</org_study_id>
    <nct_id>NCT01735097</nct_id>
  </id_info>
  <brief_title>Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis</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>
      Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical&#xD;
      keratosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis&#xD;
      patients (both male and female; age range 18- 60 years) will be recruited from an arsenic&#xD;
      affected area. Study population will be divided randomly into two equal groups: one group&#xD;
      will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin&#xD;
      E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL)&#xD;
      and urine (50 mL) samples will be collected before starting the study and estimate the amount&#xD;
      of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL)&#xD;
      samples will be collected both before and completion of the study to see the efficacy and&#xD;
      safety of the drug. Clinical examinations will be done at regular interval (two weeks).&#xD;
      Clinical features and adverse effects will be recorded using a structured data collection&#xD;
      sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin,&#xD;
      creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of&#xD;
      N. sativa on palmer arsenical keratosis patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 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>Clinical improvement of signs and symptoms of palmer arsenical keratosis</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor.&#xD;
Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arsenic level in nails</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of serum vitamin E levels</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>To see any change in the concentration of plasma vitamin E levels after use of N.sativa capsules. This parameter will be estimated by spectrophotometric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of serum total cholesterol levels</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>To see any change in the concentration of serum bilirubin, transaminase levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>0 week (baseline), 12 weeks (end)</time_frame>
    <description>To see any change in the concentration of blood urea and serum creatinine levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Arsenical Keratosis</condition>
  <arm_group>
    <arm_group_label>Arsenical keratosis (Study)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arsenical keratosis (Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin E (200 mg, soft capsule) plus Placebo (refined oil in soft capsule with same size and color as that contains N sativa) twice daily, orally for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin E</intervention_name>
    <description>Vitamin E (200 mg, soft capsule)</description>
    <arm_group_label>Arsenical keratosis (Control)</arm_group_label>
    <arm_group_label>Arsenical keratosis (Study)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nigella sativa</intervention_name>
    <description>Nigella sativa (200 mg, soft capsule)</description>
    <arm_group_label>Arsenical keratosis (Study)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)</description>
    <arm_group_label>Arsenical keratosis (Control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate palmer arsenical keratosis&#xD;
&#xD;
          -  Patient drinking arsenic contaminated water (more than 0.05 mg/L) for more than six&#xD;
             months&#xD;
&#xD;
          -  Subjects those voluntarily agree to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient received treatment of arsenicosis for the last three months&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lactating mother&#xD;
&#xD;
          -  Eczema&#xD;
&#xD;
          -  Psoriasis&#xD;
&#xD;
          -  Contact dermatitis&#xD;
&#xD;
          -  Tuberculosis&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Patients with hepatic and renal impairment&#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 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 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, Department of Pharmacology</investigator_title>
  </responsible_party>
  <keyword>Arsenic</keyword>
  <keyword>Keratosis</keyword>
  <keyword>Nigella sativa</keyword>
  <keyword>Palm</keyword>
  <keyword>Vitamin E</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>Vitamin E</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/NCT01735097
org study id: BSMMU-002-CT
nct id: NCT01735097
lead sponsor: 
has dmc: No
Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical
      keratosis
Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis
      patients (both male and female; age range 18- 60 years) will be recruited from an arsenic
      affected area. Study population will be divided randomly into two equal groups: one group
      will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin
      E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL)
      and urine (50 mL) samples will be collected before starting the study and estimate the amount
      of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL)
      samples will be collected both before and completion of the study to see the efficacy and
      safety of the drug. Clinical examinations will be done at regular interval (two weeks).
      Clinical features and adverse effects will be recorded using a structured data collection
      sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin,
      creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of
      N. sativa on palmer arsenical keratosis patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Clinical improvement of signs and symptoms of palmer arsenical keratosis
time frame: up to 12 weeks
description: Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor.
Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring.
measure: Arsenic level in nails
time frame: 0 week (baseline), 12 weeks (end)
description: Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment.
measure: Estimation of serum vitamin E levels
time frame: 0 week (baseline), 12 weeks (end)
description: To see any change in the concentration of plasma vitamin E levels after use of N.sativa capsules. This parameter will be estimated by spectrophotometric method.
measure: Estimation of serum total cholesterol levels
time frame: 0 week (baseline), 12 weeks (end)
description: To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method.
measure: Liver function
time frame: 0 week (baseline), 12 weeks (end)
description: To see any change in the concentration of serum bilirubin, transaminase levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.
measure: Renal function
time frame: 0 week (baseline), 12 weeks (end)
description: To see any change in the concentration of blood urea and serum creatinine levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.
arm group label: Arsenical keratosis (Study)
arm group type: Experimental
description: Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks
arm group label: Arsenical keratosis (Control)
arm group type: Active Comparator
description: Vitamin E (200 mg, soft capsule) plus Placebo (refined oil in soft capsule with same size and color as that contains N sativa) twice daily, orally for 12 weeks
intervention type: Dietary Supplement
intervention name: Vitamin E
description: Vitamin E (200 mg, soft capsule)
arm group label: Arsenical keratosis (Control)
arm group label: Arsenical keratosis (Study)
intervention type: Dietary Supplement
intervention name: Nigella sativa
description: Nigella sativa (200 mg, soft capsule)
arm group label: Arsenical keratosis (Study)
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)
arm group label: Arsenical keratosis (Control)
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, Department of Pharmacology
mesh term: Keratosis, Actinic
mesh term: Keratosis
mesh term: Vitamin E