xml: <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/NCT06002893</url>
    </required_header>
    <id_info>
      <org_study_id>AK/08.08.2023/01</org_study_id>
      <nct_id>NCT06002893</nct_id>
    </id_info>
    <brief_title>The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive</brief_title>
    <official_title>The Antihypercholestrolemic Pharmacological Effect of a Combined Supplement of Amla Fruit, Walnut Leaves, Red Yeast Rice, and Olive Fruit Extracts Leads to Improvement in Circulatory Levels of LDL-C and Remnant Cholesterol</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Liaquat University of Medical &amp; Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>KU Leuven</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Liaquat University of Medical &amp; Health Sciences</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly&#xD;
        among patients who are intolerant or refractory to prescription statins, or who desire&#xD;
        alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether&#xD;
        they previously experienced statin intolerance or not. A growing body of preclinical and&#xD;
        clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and&#xD;
        walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present exploratory study aimed to assess the safety, efficacy, and patient's&#xD;
        satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf&#xD;
        extracts (Cholesfytol NG®) on total cholesterol (TC), low-density lipoprotein - cholesterol&#xD;
        (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein -&#xD;
        cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic&#xD;
        patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 19, 2020</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Cholesfytol NG®) supplement treatment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in blood lipid profile</measure>
      <time_frame>2-months</time_frame>
      <description>Decrease in blood total cholesterol (TC) concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in blood lipid profile</measure>
      <time_frame>2-months</time_frame>
      <description>Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in blood lipid profile</measure>
      <time_frame>2-months</time_frame>
      <description>Decrease in blood triglycerides (TG) concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in blood lipid profile</measure>
      <time_frame>2-months</time_frame>
      <description>Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Decrease in blood lipid profile</measure>
      <time_frame>2-months</time_frame>
      <description>Change in blood remnant cholesterol (RC) concentration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of side effects</measure>
      <time_frame>2-months</time_frame>
      <description>Number of patients reporting myalgia</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">221</enrollment>
    <condition>Hyperlipidemia</condition>
    <arm_group>
      <arm_group_label>Cholesfytol NG®) supplement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Cholesfytol NG®) supplement</intervention_name>
      <description>General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement</description>
      <arm_group_label>Cholesfytol NG®) supplement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 21 years&#xD;
  &#xD;
            -  Both male or female&#xD;
  &#xD;
            -  Blood total cholesterol (TC) level ≥ 200 mg/dL&#xD;
  &#xD;
            -  Blood low-density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL&#xD;
  &#xD;
            -  With or without myalgia and/or diabetes&#xD;
  &#xD;
            -  No prior treatment of cholesterol-lowering agents and/or patients whose cholesterol-&#xD;
               lowering treatment did not allow them to reach LDL-C target&#xD;
  &#xD;
            -  Patients who had stopped their cholesterol-lowering treatment because of side effects&#xD;
               including myalgia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant nor breastfeeding patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven</name>
        <address>
          <city>Leuven</city>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Liaquat University of Medical &amp; Health Sciences</investigator_affiliation>
      <investigator_full_name>Dr. Amjad Khan</investigator_full_name>
      <investigator_title>Professor of Clinical Biochemistry and Experimental Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperlipidemias</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002893
  org study id: AK/08.08.2023/01
  nct id: NCT06002893
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly
        among patients who are intolerant or refractory to prescription statins, or who desire
        alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether
        they previously experienced statin intolerance or not. A growing body of preclinical and
        clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and
        walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.
  The present exploratory study aimed to assess the safety, efficacy, and patient's
        satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf
        extracts (Cholesfytol NG®) on total cholesterol (TC), low-density lipoprotein - cholesterol
        (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein -
        cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic
        patients.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Cholesfytol NG®) supplement treatment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in blood lipid profile
  time frame: 2-months
  description: Decrease in blood total cholesterol (TC) concentration
  measure: Change in blood lipid profile
  time frame: 2-months
  description: Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration
  measure: Change in blood lipid profile
  time frame: 2-months
  description: Decrease in blood triglycerides (TG) concentration
  measure: Change in blood lipid profile
  time frame: 2-months
  description: Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration
  measure: Decrease in blood lipid profile
  time frame: 2-months
  description: Change in blood remnant cholesterol (RC) concentration
  measure: Rate of side effects
  time frame: 2-months
  description: Number of patients reporting myalgia
  arm group label: Cholesfytol NG®) supplement
  arm group type: Experimental
  description: Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months.
  intervention type: Dietary Supplement
  intervention name: Cholesfytol NG®) supplement
  description: General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement
  arm group label: Cholesfytol NG®) supplement
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: Liaquat University of Medical & Health Sciences
  investigator full name: Dr. Amjad Khan
  investigator title: Professor of Clinical Biochemistry and Experimental Medicine
  mesh term: Hyperlipidemias
  sharing ipd: No