<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/NCT02207101</url>
  </required_header>
  <id_info>
    <org_study_id>EB/141005/OXY-2/CE</org_study_id>
    <nct_id>NCT02207101</nct_id>
  </id_info>
  <brief_title>Study to Assess the Effect of OXYJUN on Ejection Fraction and Markers of Cardiovascular Injury</brief_title>
  <acronym>Enduoxy</acronym>
  <official_title>The Effect of Investigational Product E-OJ-01 (OXYJUN) on Left Ventricular Ejection Fraction and Markers of Cardiovascular Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vedic Lifesciences Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Enovate Biolife Pvt Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vedic Lifesciences Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Young athletes are usually regarded as a special subgroup of healthy individuals with a&#xD;
      unique lifestyle who are apparently invulnerable and often capable of extraordinary physical&#xD;
      achievement. Most athletic disciplines to some extent combine endurance and strength modes of&#xD;
      physical conditioning. Acute responses to endurance exercise training include substantial&#xD;
      increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood&#xD;
      pressure in-spite of this, high intensity chronic training such as marathons, very long&#xD;
      distance bicycle racing etc., can lead to transient acute volume overload of the atria and&#xD;
      right ventricle, with transient reductions in right ventricular ejection fraction and&#xD;
      elevations of cardiac biomarkers. Although these biomarkers generally normalize back within&#xD;
      seven to ten days, these transient changes may sooner or later mark the beginning of&#xD;
      processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .&#xD;
&#xD;
      Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been&#xD;
      no new advancements in finding an alternate option which can protect the cardio vascular&#xD;
      system in the athletes.&#xD;
&#xD;
      Hence in order to address the need of the hour and also to avoid the cardio vascular risk in&#xD;
      athletes along with improvising the endurance capacity, Enovate Biolife is in the process of&#xD;
      development of an innovative product &quot;E-OJ-01&quot;.&#xD;
&#xD;
      E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes&#xD;
      by enhancing ejection fraction which in turn improves cardiac output. This finally is&#xD;
      hypothysed to increase the maximal oxygen uptake capacity in athletes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Left Ventricular Ejection Fraction</measure>
    <time_frame>Day 0, Day 28 and Day 56</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Troponin-T</measure>
    <time_frame>Day 0 and Day 56</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Cardiac Function in Young Athletes</condition>
  <arm_group>
    <arm_group_label>E-OJ-01 (OXYJUN)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>E-OJ-01 (OXYJUN). Dose: 01 capsule to be taken orally daily after lunch.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo capsules [for E-OJ-01 (OXYJUN)] composed of microcrystalline cellulose. Dose: 01 capsule to be taken orally daily after lunch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>E-OJ-01 (OXYJUN)</intervention_name>
    <arm_group_label>E-OJ-01 (OXYJUN)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male athletes aged 18 - 40 years having endurance exercise not less than 3-4 hrs. /&#xD;
             week since at least last 12 weeks.&#xD;
&#xD;
          -  Subject with left ventricular ejection fraction not less than 55% and not more than&#xD;
             70%.&#xD;
&#xD;
          -  Subjects having body fat less than 16% as determined by skin fold assessment.&#xD;
&#xD;
          -  Subject is willing to refrain from vigorous physical activity 12 hrs prior to clinic&#xD;
             visit.&#xD;
&#xD;
          -  Subject is a non-alcoholic/ non-smoker.&#xD;
&#xD;
          -  Subject understands the study procedures and signs forms providing informed consent to&#xD;
             participate in the study and authorization for release of relevant protected health&#xD;
             information to the study Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left Ventricular Ejection fraction less than 55 per cent by echocardiogram.&#xD;
&#xD;
          -  Subjects suffering from anemia as defined by Hb levels ≤ 10 g/ dl.&#xD;
&#xD;
          -  Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic&#xD;
             blood pressure ≥ 100 mm Hg) as defined by the average blood pressure measured at&#xD;
             screening.&#xD;
&#xD;
          -  History of coronary artery disease, myocardial infarction, hypertension or diabetes&#xD;
             mellitus.&#xD;
&#xD;
          -  History of cardiomyopathy, congenital heart defect, open heart surgery, or ongoing&#xD;
             arrhythmia.&#xD;
&#xD;
          -  Subjects having laboratory finding beyond specified normal limits at screening and in&#xD;
             the opinion of the investigator possess significant threat for the study subject.&#xD;
&#xD;
          -  Subject has a history or presence of clinically important renal, hepatic, endocrine&#xD;
             (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or&#xD;
             neurologic disorders that, in the judgment of the Investigator, would interfere with&#xD;
             the subject's ability to provide informed consent, comply with the study protocol&#xD;
             (which might confound the interpretation of the study results), or put the subject at&#xD;
             undue risk.&#xD;
&#xD;
          -  Use of any sleep aid medication within four days prior to each test day.&#xD;
&#xD;
          -  Use of any psychotropic medication within four weeks of screening and throughout the&#xD;
             study.&#xD;
&#xD;
          -  Subject has a history, in the judgment of the Investigator, of a psychological illness&#xD;
             or condition such as to interfere with the subject's ability to understand the&#xD;
             requirements of the study.&#xD;
&#xD;
          -  Use of antibiotics or signs of active systemic infection. Treatment visits will be&#xD;
             rescheduled to allow the subject to wash off of the antibiotic for at least five days&#xD;
             prior to any test visit. Use of any other dietary supplements or herbal products.&#xD;
&#xD;
          -  Recent history of (within 12 months of screening visit 1) or strong potential for&#xD;
             alcohol or substance abuse.&#xD;
&#xD;
          -  Subject has a known allergy or sensitivity to herbal product(s).&#xD;
&#xD;
          -  Subject has had exposure to any non-registered drug product within 30 days prior to&#xD;
             the screening visit.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ravi Chavan, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Suburban Diagnostics</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400053</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 9, 2015</last_update_submitted>
  <last_update_submitted_qc>July 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Young athletes</keyword>
  <keyword>Cardiac endurance</keyword>
  <keyword>Herbal</keyword>
  <keyword>Ejection Fraction</keyword>
  <keyword>Basic Research</keyword>
  <keyword>Cardiovascular Injury</keyword>
  <!-- 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/NCT02207101
org study id: EB/141005/OXY-2/CE
nct id: NCT02207101
lead sponsor: 
collaborator: 
has dmc: No
Young athletes are usually regarded as a special subgroup of healthy individuals with a
      unique lifestyle who are apparently invulnerable and often capable of extraordinary physical
      achievement. Most athletic disciplines to some extent combine endurance and strength modes of
      physical conditioning. Acute responses to endurance exercise training include substantial
      increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood
      pressure in-spite of this, high intensity chronic training such as marathons, very long
      distance bicycle racing etc., can lead to transient acute volume overload of the atria and
      right ventricle, with transient reductions in right ventricular ejection fraction and
      elevations of cardiac biomarkers. Although these biomarkers generally normalize back within
      seven to ten days, these transient changes may sooner or later mark the beginning of
      processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .

      Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been
      no new advancements in finding an alternate option which can protect the cardio vascular
      system in the athletes.

      Hence in order to address the need of the hour and also to avoid the cardio vascular risk in
      athletes along with improvising the endurance capacity, Enovate Biolife is in the process of
      development of an innovative product "E-OJ-01".

      E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes
      by enhancing ejection fraction which in turn improves cardiac output. This finally is
      hypothysed to increase the maximal oxygen uptake capacity in athletes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Change in Left Ventricular Ejection Fraction
time frame: Day 0, Day 28 and Day 56
measure: Change in Serum Troponin-T
time frame: Day 0 and Day 56
arm group label: E-OJ-01 (OXYJUN)
arm group type: Active Comparator
description: E-OJ-01 (OXYJUN). Dose: 01 capsule to be taken orally daily after lunch.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo capsules [for E-OJ-01 (OXYJUN)] composed of microcrystalline cellulose. Dose: 01 capsule to be taken orally daily after lunch.
intervention type: Dietary Supplement
intervention name: E-OJ-01 (OXYJUN)
arm group label: E-OJ-01 (OXYJUN)
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ravi Chavan, MD
role: Principal Investigator
facility: 
country: India
responsible party type: Sponsor