<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/NCT02203227</url>
  </required_header>
  <id_info>
    <org_study_id>OLS-SH/06-14 VER 01</org_study_id>
    <nct_id>NCT02203227</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia</brief_title>
  <official_title>Efficacy and Safety Study of Dietary Supplements (BioTurmin, BioTurmin-WD and MaQxan) on Cotinine Level and Oxidative Stress Marker in Chronic Smokers Having Mild to Moderate Hyperlipidemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olive Lifesciences Pvt Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Olive Lifesciences Pvt Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy and safety of dietary supplements&#xD;
      (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic&#xD;
      smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary&#xD;
      supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers&#xD;
      having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive&#xD;
      the dietary supplements and placebo for 60 days. The efficacy of the supplements will be&#xD;
      measured by estimating cotinine and malondialdehyde level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</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>change in urine cotinine and serum oxidative stress marker (malondialdehyde) level</measure>
    <time_frame>Baseline, on day 30 and on day 60</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serum lipid profile</measure>
    <time_frame>Baseline, on day 30 and on day 60</time_frame>
    <description>Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety and tolerability (composite measure)</measure>
    <time_frame>Baseline, on day 30 and on day 60</time_frame>
    <description>Physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology [complete blood count (CBC)], biochemical tests (serum urea, serum creatinine), liver function test and urine analysis</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Smokers</condition>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsule containing 250 mg of placebo, two times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BioTurmin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsule containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BioTurmin-WD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsule containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MaQxan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsule containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BioTurmin (Curcuma longa rhizomes extract)</intervention_name>
    <arm_group_label>BioTurmin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BioTurmin-WD (Water dispersible curcuminoids)</intervention_name>
    <arm_group_label>BioTurmin-WD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>MaQxan</intervention_name>
    <arm_group_label>MaQxan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men &gt; 20 years&#xD;
&#xD;
          -  Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild&#xD;
             to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC &gt;200 mg/dL and/or HDL-C &lt;40&#xD;
             mg/dL)&#xD;
&#xD;
          -  Being mentally competent and able to understand all study requirements and sign the&#xD;
             informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Patients with severe liver, renal, cardiac or brain diseases.&#xD;
&#xD;
          -  Unable to complete follow up.&#xD;
&#xD;
          -  Subjects on any medication like diuretics.&#xD;
&#xD;
          -  Allergic to any medication.&#xD;
&#xD;
          -  With a history of alcohol and/or drug abuse.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Venkateshwarlu K, MD (Ayur)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sreenivasa Clinic Diabetic Research Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shivaprasad H N, Ph.D</last_name>
    <phone>918971489704</phone>
    <email>shiv@olivelifesciences.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bhanumathy M, M Pharma</last_name>
    <phone>919986411152</phone>
    <email>bhanumathy@olivelifesciences.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sreenivasa Clinic Diabetic Research Center</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560050</zip>
        <country>India</country>
      </address>
    </facility>
    <contact>
      <last_name>Venkateshwarlu K, MD (Ayur)</last_name>
      <phone>919945232107</phone>
      <email>drvenkatesh64@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Raveendra K, MD</last_name>
      <phone>919448134587</phone>
      <email>drkrraveendra@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Venkateshwarlu K, MD (Ayur)</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Raveendra K, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://www.nlm.nih.gov/medlineplus/dietarysupplements.html</url>
    <description>Dietary supplements</description>
  </link>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&amp;objectHandle=DBMaint&amp;APPLICATION_NAME=drugportal&amp;actionHandle=default&amp;nextPage=jsp/drugportal/ResultScreen.jsp&amp;TXTSUPERLISTID=0977052440&amp;QV1=CURCUMA+LONGA</url>
    <description>Curcuma longa</description>
  </link>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&amp;objectHandle=DBMaint&amp;APPLICATION_NAME=drugportal&amp;actionHandle=default&amp;nextPage=jsp/drugportal/ResultScreen.jsp&amp;TXTSUPERLISTID=0090131434&amp;QV1=TAGETES+ERECTA+EXTRACT</url>
    <description>Tagetes erecta</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dietary supplements</keyword>
  <keyword>Cotinine level</keyword>
  <keyword>Malondialdehyde</keyword>
  <keyword>Chronic smokers</keyword>
  <keyword>Hyperlipidemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Turmeric extract</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/NCT02203227
org study id: OLS-SH/06-14 VER 01
nct id: NCT02203227
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the efficacy and safety of dietary supplements
      (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic
      smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.
In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary
      supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers
      having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive
      the dietary supplements and placebo for 60 days. The efficacy of the supplements will be
      measured by estimating cotinine and malondialdehyde level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: change in urine cotinine and serum oxidative stress marker (malondialdehyde) level
time frame: Baseline, on day 30 and on day 60
measure: Change in serum lipid profile
time frame: Baseline, on day 30 and on day 60
description: Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)
measure: Safety and tolerability (composite measure)
time frame: Baseline, on day 30 and on day 60
description: Physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology [complete blood count (CBC)], biochemical tests (serum urea, serum creatinine), liver function test and urine analysis
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsule containing 250 mg of placebo, two times a day
arm group label: BioTurmin
arm group type: Experimental
description: Capsule containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day
arm group label: BioTurmin-WD
arm group type: Experimental
description: Capsule containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day
arm group label: MaQxan
arm group type: Experimental
description: Capsule containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: BioTurmin (Curcuma longa rhizomes extract)
arm group label: BioTurmin
intervention type: Dietary Supplement
intervention name: BioTurmin-WD (Water dispersible curcuminoids)
arm group label: BioTurmin-WD
intervention type: Dietary Supplement
intervention name: MaQxan
arm group label: MaQxan
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Venkateshwarlu K, MD (Ayur)
role: Principal Investigator
affiliation: Sreenivasa Clinic Diabetic Research Center
last name: Shivaprasad H N, Ph.D
phone: 918971489704
email: shiv@olivelifesciences.com
last name: Bhanumathy M, M Pharma
phone: 919986411152
email: bhanumathy@olivelifesciences.com
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: India
url: http://www.nlm.nih.gov/medlineplus/dietarysupplements.html
description: Dietary supplements
url: http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0977052440&QV1=CURCUMA+LONGA
description: Curcuma longa
url: http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0090131434&QV1=TAGETES+ERECTA+EXTRACT
description: Tagetes erecta
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
mesh term: Turmeric extract