<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/NCT01680211</url>
  </required_header>
  <id_info>
    <org_study_id>OL-S-OB-LP/03-12</org_study_id>
    <secondary_id>CTRI/2012/05/002678</secondary_id>
    <nct_id>NCT01680211</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients</brief_title>
  <official_title>Efficacy and Safety Study of Herbal Supplements (SR-L-01, SR-B-01 and SI-S-01) in the Management of Prediabetes and 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>
      Objective of this study is to determine the safety and efficacy of administration of herbal&#xD;
      supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks&#xD;
      in the management of prediabetes and mild to moderate hyperlipidemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Blood Sugar and lipid profiles</measure>
    <time_frame>baseline and 6 weeks</time_frame>
    <description>Change in of blood sugar out come will be measured by Fasting Blood Sugar (FBS), Oral Glucose Tolerance Test (OGTT) and Postprandial Blood Sugar (PPBS). Change in lipid profiles are measured by Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical laboratory evaluations</measure>
    <time_frame>0 and week 6</time_frame>
    <description>Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Prediabetes</condition>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>Salacia bark extract (SR-B-01) and TLC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sesame seeds extract (SI-S-01) and TLC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salacia leaf extract (SR-L-01) and TLC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo and TLC</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Salacia bark extract</intervention_name>
    <arm_group_label>Salacia bark extract (SR-B-01) and TLC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Salacia leaf extract</intervention_name>
    <arm_group_label>Salacia leaf extract (SR-L-01) and TLC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sesame seed extract</intervention_name>
    <arm_group_label>Sesame seeds extract (SI-S-01) and TLC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TLC</intervention_name>
    <description>Lifestyle changes include diet, exercise, weight loss, etc.</description>
    <arm_group_label>Placebo and TLC</arm_group_label>
    <arm_group_label>Salacia bark extract (SR-B-01) and TLC</arm_group_label>
    <arm_group_label>Salacia leaf extract (SR-L-01) and TLC</arm_group_label>
    <arm_group_label>Sesame seeds extract (SI-S-01) and TLC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo and TLC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC &gt;200 mg/dL and with&#xD;
             no or one of the below risk factors&#xD;
&#xD;
               -  Current cigarette smoking&#xD;
&#xD;
               -  Family history of premature Coronary Heart Disease(CHD); in male first degree&#xD;
                  relative &lt;55 years; in female first degree relative &lt;65 years)&#xD;
&#xD;
               -  Hypertension (BP &gt;140/90 mmHg or on antihypertensive medication)&#xD;
&#xD;
               -  Low HDL-C (&lt;40 mg/dL)&#xD;
&#xD;
               -  Age (men &gt; 40 years)&#xD;
&#xD;
          2. Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140&#xD;
             to ≤ 200 mg/dL)&#xD;
&#xD;
          3. Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125&#xD;
             mg/dL)&#xD;
&#xD;
          4. Being mentally competent and able to understand all study requirements and sign the&#xD;
             informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with severe liver, renal, cardiac or brain diseases.&#xD;
&#xD;
          2. Pregnant or lactating women or women of child bearing potential whom are not&#xD;
             practicing a reliable form of birth control (either with IUD or with stable usage of&#xD;
             oral contraceptives).&#xD;
&#xD;
          3. Unable to complete follow up.&#xD;
&#xD;
          4. Subjects on any medication that would affect evaluation like Statins.&#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>K R Raveendra, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Srinivasa Clinic &amp; Diabetic Care Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Srinivasa Clinic &amp; Diabetic Care Center</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560050</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 3, 2012</last_update_submitted>
  <last_update_submitted_qc>September 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood Sugar,</keyword>
  <keyword>Lipoproteins,</keyword>
  <keyword>Salacia,</keyword>
  <keyword>Sesame,</keyword>
  <keyword>Prediabetes,</keyword>
  <keyword>Hyperlipidemia,</keyword>
  <keyword>Herbal supplement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</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/NCT01680211
org study id: OL-S-OB-LP/03-12
secondary id: CTRI/2012/05/002678
nct id: NCT01680211
lead sponsor: 
has dmc: Yes
Objective of this study is to determine the safety and efficacy of administration of herbal
      supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks
      in the management of prediabetes and mild to moderate hyperlipidemia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in Blood Sugar and lipid profiles
time frame: baseline and 6 weeks
description: Change in of blood sugar out come will be measured by Fasting Blood Sugar (FBS), Oral Glucose Tolerance Test (OGTT) and Postprandial Blood Sugar (PPBS). Change in lipid profiles are measured by Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC).
measure: Clinical laboratory evaluations
time frame: 0 and week 6
description: Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis
arm group label: Salacia bark extract (SR-B-01) and TLC
arm group type: Experimental
description: Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)
arm group label: Sesame seeds extract (SI-S-01) and TLC
arm group type: Experimental
description: Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)
arm group label: Salacia leaf extract (SR-L-01) and TLC
arm group type: Experimental
description: Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)
arm group label: Placebo and TLC
arm group type: Placebo Comparator
description: Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)
intervention type: Dietary Supplement
intervention name: Salacia bark extract
arm group label: Salacia bark extract (SR-B-01) and TLC
intervention type: Dietary Supplement
intervention name: Salacia leaf extract
arm group label: Salacia leaf extract (SR-L-01) and TLC
intervention type: Dietary Supplement
intervention name: Sesame seed extract
arm group label: Sesame seeds extract (SI-S-01) and TLC
intervention type: Behavioral
intervention name: TLC
description: Lifestyle changes include diet, exercise, weight loss, etc.
arm group label: Placebo and TLC
arm group label: Salacia bark extract (SR-B-01) and TLC
arm group label: Salacia leaf extract (SR-L-01) and TLC
arm group label: Sesame seeds extract (SI-S-01) and TLC
intervention type: Other
intervention name: Placebo
arm group label: Placebo and TLC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: K R Raveendra, M.D
role: Principal Investigator
affiliation: Srinivasa Clinic & Diabetic Care Center
facility: 
country: India
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
mesh term: Prediabetic State
mesh term: Glucose Intolerance