<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/NCT02187757</url>
  </required_header>
  <id_info>
    <org_study_id>Prelip/Nutra001/PMI13</org_study_id>
    <nct_id>NCT02187757</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels</brief_title>
  <acronym>Prelip</acronym>
  <official_title>A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, Study to Evaluate the Safety, Efficacy and Tolerability of PreLipid®, a Twice-daily Nutritional Supplement in Subjects With Higher Than Normal Blood Lipid Levels</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PreEmptive Meds, Pvt. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>PreEmptive Meds, Pvt. Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood&#xD;
      lipid levels&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate&#xD;
      the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in&#xD;
      subjects with higher than normal blood lipid levels&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels</measure>
    <time_frame>Day 1 (Baseline) to Day 90 (End of Study)</time_frame>
    <description>Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of Dietary Supplement PreLipid 600 mg twice-daily</measure>
    <time_frame>Day 1(Baseline) to Day 90 (End of Study)</time_frame>
    <description>Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day 1) to End of Study (Day 90) and Alkaline Phosphatase (ALP) from baseline (Day 1) to End of Study (Day 90)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Glycemic Status</measure>
    <time_frame>Day 1 (Baseline) to Day 90 (End of Study)</time_frame>
    <description>To assess percentage changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety of Dietary Supplement PreLipid 600 mg twice-daily with Kidney Function</measure>
    <time_frame>Baseline (Day 1) to End of Study (Day 90)</time_frame>
    <description>Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to End of Study (Day 90); Serum Creatinine from baseline (Day 1) to End of Study (Day 90)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>PreLipid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90days along with lifestyle modification.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 600 mg capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Study Dietary Supplement (Prelipid 500 mg capsules)</intervention_name>
    <description>Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.</description>
    <arm_group_label>PreLipid</arm_group_label>
    <other_name>PreLipid, Natural Cholesterol Supplement, Predisease</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo 600 mg capsules</arm_group_label>
    <other_name>Placebo 600 mg capsules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Newly diagnosed Male or Female participants with higher than normal cholesterol levels&#xD;
        defined by the American Heart Association, National Cholesterol Education Program (NCEP)&#xD;
        and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes&#xD;
        (TLCs) and drug therapy in different risk categories:&#xD;
&#xD;
          1. Age ≥ 18 years to ≤ 65 years&#xD;
&#xD;
          2. LDL cholesterol levels &gt;120mg/dl&#xD;
&#xD;
          3. Ability to understand and willingness to sign and date a written Informed Consent&#xD;
             Document at the screening visit before any protocol- specific procedures are performed&#xD;
             and willing to adhere to the protocol and entire trial procedures -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous&#xD;
             transluminal coronary angioplasty (PTCA) or angina pectoris in the past.&#xD;
&#xD;
          2. Cardiac status New York Heart Association class III-IV&#xD;
&#xD;
          3. Uncotrolled blood pressure &gt; 150 mmhg systolic and &gt; 100 mmhg diastolic&#xD;
&#xD;
          4. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl&#xD;
             for males and ≥ 1.4 mg/dl for female&#xD;
&#xD;
          5. Clinically significant peripheral edema&#xD;
&#xD;
          6. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or&#xD;
             aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X&#xD;
             ULN)&#xD;
&#xD;
          7. Participants on steroid&#xD;
&#xD;
          8. Pregnancy or lactating women&#xD;
&#xD;
          9. Known hypersensitivity to any of the study drugs&#xD;
&#xD;
         10. Any malignancy within the last 5 years, with exception of adequately treated basal or&#xD;
             squamous cell carcinoma of the skin or adequately treated carcinoma insitu.&#xD;
&#xD;
         11. Current addiction or current alcohol abuse or history of substance or alcohol abuse&#xD;
             within the last 2 years&#xD;
&#xD;
         12. Subject is the investigator or any sub-investigator, research assistant, pharmacist,&#xD;
             study coordinator, other staff or relative thereof directly involved in the conduct of&#xD;
             the protocol&#xD;
&#xD;
         13. Mental condition rendering the subject unable to understand the nature, scope and&#xD;
             possible consequences of the study.&#xD;
&#xD;
         14. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to&#xD;
             return for follow up visits and unlikelihood completing of the study&#xD;
&#xD;
         15. Any disease or condition that in the opinion of the investigator and/or sponsor may&#xD;
             interfere with the completion of the studyevaluation.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ravi Kasliwal, MD, DM, FIMSA</last_name>
    <role>Study Chair</role>
    <affiliation>Medanta, The Medicity, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Clinical &amp; Preventive Cardiology, Heart Institute</name>
      <address>
        <city>Gurgaon</city>
        <state>Delhi</state>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Life Care Institute of Medical Science &amp; Research</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bhatia Hospital Medical Research Society</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Vikas Govind Pai Clinical Research Foundation</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Escorts Hospital</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pace Clinical Research Center</name>
      <address>
        <city>Bangalore</city>
        <state>Tamil Nadu</state>
        <zip>560043</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singvi Health Centre</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600079</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rangammal Hospital</name>
      <address>
        <city>Tiruvannamalai</city>
        <state>Tamil Nadu</state>
        <zip>606003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>May 14, 2015</last_update_submitted>
  <last_update_submitted_qc>May 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medanta, The Medicity, India</investigator_affiliation>
    <investigator_full_name>Joe Fenn</investigator_full_name>
    <investigator_title>Chairman, Department of Clinical &amp; Preventive Cardiology</investigator_title>
  </responsible_party>
  <keyword>Dyslipidemia</keyword>
  <keyword>High cholesterol</keyword>
  <keyword>High LDL</keyword>
  <keyword>Triglycerides</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
  </condition_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/NCT02187757
org study id: Prelip/Nutra001/PMI13
nct id: NCT02187757
lead sponsor: 
collaborator: 
has dmc: Yes
Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood
      lipid levels
A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate
      the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in
      subjects with higher than normal blood lipid levels
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels
time frame: Day 1 (Baseline) to Day 90 (End of Study)
description: Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days
measure: Safety of Dietary Supplement PreLipid 600 mg twice-daily
time frame: Day 1(Baseline) to Day 90 (End of Study)
description: Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day 1) to End of Study (Day 90) and Alkaline Phosphatase (ALP) from baseline (Day 1) to End of Study (Day 90)
measure: Changes in Glycemic Status
time frame: Day 1 (Baseline) to Day 90 (End of Study)
description: To assess percentage changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months.
measure: Safety of Dietary Supplement PreLipid 600 mg twice-daily with Kidney Function
time frame: Baseline (Day 1) to End of Study (Day 90)
description: Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to End of Study (Day 90); Serum Creatinine from baseline (Day 1) to End of Study (Day 90)
arm group label: PreLipid
arm group type: Experimental
description: Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90days along with lifestyle modification.
arm group label: Placebo 600 mg capsules
arm group type: Placebo Comparator
description: Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.
intervention type: Dietary Supplement
intervention name: Study Dietary Supplement (Prelipid 500 mg capsules)
description: Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.
arm group label: PreLipid
other name: PreLipid, Natural Cholesterol Supplement, Predisease
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo 600 mg capsules
other name: Placebo 600 mg capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ravi Kasliwal, MD, DM, FIMSA
role: Study Chair
affiliation: Medanta, The Medicity, India
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Medanta, The Medicity, India
investigator full name: Joe Fenn
investigator title: Chairman, Department of Clinical & Preventive Cardiology
mesh term: Hyperlipidemias