<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/NCT03262805</url>
  </required_header>
  <id_info>
    <org_study_id>EB/170401/LC/OA</org_study_id>
    <nct_id>NCT03262805</nct_id>
  </id_info>
  <brief_title>To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study</brief_title>
  <acronym>LEAP</acronym>
  <official_title>To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vedic Lifesciences Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vedic Lifesciences Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      The current study is designed to assess the pain relieving effect of 4-weeks ingestion of&#xD;
      this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per&#xD;
      day) in mild to moderate OA subjects. Also, the current study intends to assess the safety&#xD;
      and efficacy of long term administration of Lanconone in larger sample size as compared to&#xD;
      the earlier studies.15,16 The study also intends to analyse the effect on joint stiffness and&#xD;
      function by means of self-reported WOMAC &amp; Lequesne questionnaire.The effect of IP on&#xD;
      clinically proven biomarker, hs-CRP will be analyzed in comparison with placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has been planned to evaluate the efficacy of Lanconone® in enhancing the overall&#xD;
      joint health in the population of ≥ 40 years of age during the daily life activities by the&#xD;
      reduction of the joint pain and discomfort. Assessment of pain is the primary objective which&#xD;
      will be done by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).&#xD;
      It is a widely used, proprietary set of standardized questionnaires used by health&#xD;
      professionals to evaluate the severity of osteoarthritis of the knee and hip, including pain,&#xD;
      stiffness, and physical functioning of the joints. The early onset of action (3 days after&#xD;
      commencement of the IP administration) for pain relief which was not captured in the past&#xD;
      studies, will be captured in the current study by the telephonic assessment of the study&#xD;
      subjects. Lequesne et al developed an index of severity for osteoarthritis for the knee which&#xD;
      can be used to assess the effectiveness of therapeutic interventions. Unlike the earlier&#xD;
      studies, we will use the Lequesne Functional Index (LFI) to assess the extent of joint health&#xD;
      degeneration. In relation to OA, elevated levels of hs-CRP have been correlated with symptoms&#xD;
      of joint pain and stiffness. Hence, we decided to analyze the hs-crp levels as one of the&#xD;
      secondary objectives. Also, the rescue medication consumption has been limited to lower per&#xD;
      day consumption compared to earlier studies to avoid the placebo effect influence on the&#xD;
      study results. The efficacy of the IP in sustaining the pain relieving effect will be&#xD;
      analyzed on day 35, i.e. one week after the end of the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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>
    <intervention_model_description>Randomized, double-blind, placebo-controlled, parallel group study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WOMAC pain score.</measure>
    <time_frame>28 days</time_frame>
    <description>• Change in terms of percentage reduction of joint pain from baseline to Day 28 during daily life activities assessed by WOMAC pain score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WOMAC stiffness score</measure>
    <time_frame>28 days</time_frame>
    <description>Change in terms of percentage reduction of joint pain from baseline to Day 28 joint stiffness as assessed by WOMAC stiffness score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC physical performance score.</measure>
    <time_frame>28 days</time_frame>
    <description>Change in terms of percentage reduction of joint pain from baseline to Day 28 in physical performance during daily life activities as assessed by WOMAC physical performance score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lequesne Functional Index</measure>
    <time_frame>28 days</time_frame>
    <description>% reduction in joint degradation process as from baseline to Day 28 as assessed by Lequesne Functional Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum hs-CRP levels.</measure>
    <time_frame>28 days</time_frame>
    <description>% reduction in joint pain marker from baseline to Day 28 as assessed by serum hs-CRP levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>28 days</time_frame>
    <description>% change in joint degradation related risk factor from baseline to Day 28 as assessed by BMI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% responders</measure>
    <time_frame>28 days</time_frame>
    <description>Comparison of uniformity of positive pain relieving individual response as assessed by % responders with ≥ 17% reduction in WOMAC pain score at Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue medication consumption</measure>
    <time_frame>28 days</time_frame>
    <description>Comparison of alternate analgesic therapy requirement as assessed by number of rescue medication consumption during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained effect</measure>
    <time_frame>35 days</time_frame>
    <description>• To assess the sustained drug free period as assessed by WOMAC pain score joint pain at Day 35 as compared to Day 28.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lanconone(R)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lanconone</intervention_name>
    <description>. Lanconone® is a joint pain supplement containing natural herbs such as Shyonak, Ashwagandha, Shunthi, Guggul, Chopchini, Rasna and Shallaki in therapeutic quantities and documented in the ancient scriptures as pain relievers.</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Microcrystalline cellulose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  M/F subject aged ≥ 40 to ≤ 65 with unilateral or bilateral OA of the knee for greater&#xD;
             than 3 months as presented by pain in knee.&#xD;
&#xD;
          -  Body mass index (BMI) must be 25 to 29.9 kg/m2.&#xD;
&#xD;
          -  WOMAC pain score for index joint: 10 to 16.&#xD;
&#xD;
          -  Physically active subjects as indicated by day to day involvement in the mentioned&#xD;
             physical activity namely:&#xD;
&#xD;
          -  Daily walk of 500 to 1000 meters.&#xD;
&#xD;
          -  Routine activities such as descending/ ascending stairs, standing up from a chair;&#xD;
             bending to floor; travelling by public transport, domestic cleaning etc.&#xD;
&#xD;
          -  Climbing 1 or more fleets of stairs.&#xD;
&#xD;
          -  Osteoarthritis grade I/ II (Kellgren-Lawrence classification) as confirmed by&#xD;
             radiographic evidence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of any joint replacement surgery.&#xD;
&#xD;
          -  Subjects not willing to abstain from use of NSAIDs (including low dose aspirin 50&#xD;
             mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint&#xD;
             health/ local analgesics or other traditional pain relieving therapies such as message&#xD;
             or acupuncture etc. during the study duration will be excluded.&#xD;
&#xD;
          -  Subject with uncontrolled hypertension (blood pressure: systolic ≥140 mm Hg or&#xD;
             diastolic ≥ 100 mm Hg) at screening.&#xD;
&#xD;
          -  Subjects with history of thyroid hormone derangement will have to provide a recent&#xD;
             (within 3 months) thyroid profile report indicative of euthyroid status.&#xD;
&#xD;
          -  Use of any immunosuppressive drugs in the last 12 months.&#xD;
&#xD;
          -  Use of any corticosteroids drugs in the last 3 months.&#xD;
&#xD;
          -  Subject unwilling to refrain from analgesic measures at least 48 hours before each&#xD;
             site visit.&#xD;
&#xD;
          -  FBS &gt;140 mg/dl.&#xD;
&#xD;
          -  History of restless leg syndrome.&#xD;
&#xD;
          -  Glucocorticoid injection or hyaluronic acid injection in affected joint within 3&#xD;
             months prior to enrolment.&#xD;
&#xD;
          -  Subjects with a chronic pain syndrome and in the judgment of the Investigator is&#xD;
             unlikely to respond to any therapy.&#xD;
&#xD;
          -  Smokers and tobacco users.&#xD;
&#xD;
          -  Alcohol consumption of more than 200 ml/ week&#xD;
&#xD;
          -  History of surgery in lower limb.&#xD;
&#xD;
          -  Subjects suffering from diabetic neuropathy.&#xD;
&#xD;
          -  Subjects suffering from deep vein thrombosis.&#xD;
&#xD;
          -  Pregnant / lactating women and women who are planning to get pregnant.&#xD;
&#xD;
          -  Recent (&lt; 3 months) participation in a clinical study.&#xD;
&#xD;
          -  History of major chronic hepatic, cardiovascular, neurological or immunosuppressive&#xD;
             conditions or the presence of any infections.&#xD;
&#xD;
          -  Subjects with localized trauma to the lower limb.&#xD;
&#xD;
          -  A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by&#xD;
             withdrawal symptoms.&#xD;
&#xD;
          -  Subjects planning to travel in the next 35 days or engage in any non-routine activity&#xD;
             that is likely to strain the knees.&#xD;
&#xD;
          -  Subject a history of malignancy, active gastrointestinal disease, chronic or acute&#xD;
             renal/hepatic disorders, or significant coagulation disorders.&#xD;
&#xD;
          -  Subjects on vitamins, nutritional supplement or herbal product since last 2 weeks.&#xD;
&#xD;
          -  Subjects otherwise judged by the investigator to be inappropriate for inclusion in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shalini Srivastava, MD</last_name>
    <role>Study Director</role>
    <affiliation>Enovate Biolife Pvt Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ayush Nursing Home</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400067</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kewalramani's Clinic</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400068</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KK Medical Centre</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400068</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Girandola RN, Srivastava S, Loullis CC. A clinical trial comparing Lanconone(R) with ibuprofen for rapid relief in acute joint pain. Trials. 2016 Apr 6;17:189. doi: 10.1186/s13063-016-1268-6.</citation>
    <PMID>27052991</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>April 27, 2018</last_update_submitted>
  <last_update_submitted_qc>April 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee OA</keyword>
  <keyword>Joint Pain</keyword>
  <keyword>Dietary supplement</keyword>
  <keyword>WOMAC</keyword>
  <keyword>Lequesne index</keyword>
  <keyword>hs-CRP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03262805
org study id: EB/170401/LC/OA
nct id: NCT03262805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study is designed to assess the pain relieving effect of 4-weeks ingestion of
      this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per
      day) in mild to moderate OA subjects. Also, the current study intends to assess the safety
      and efficacy of long term administration of Lanconone in larger sample size as compared to
      the earlier studies.15,16 The study also intends to analyse the effect on joint stiffness and
      function by means of self-reported WOMAC & Lequesne questionnaire.The effect of IP on
      clinically proven biomarker, hs-CRP will be analyzed in comparison with placebo.
This study has been planned to evaluate the efficacy of Lanconone® in enhancing the overall
      joint health in the population of ≥ 40 years of age during the daily life activities by the
      reduction of the joint pain and discomfort. Assessment of pain is the primary objective which
      will be done by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
      It is a widely used, proprietary set of standardized questionnaires used by health
      professionals to evaluate the severity of osteoarthritis of the knee and hip, including pain,
      stiffness, and physical functioning of the joints. The early onset of action (3 days after
      commencement of the IP administration) for pain relief which was not captured in the past
      studies, will be captured in the current study by the telephonic assessment of the study
      subjects. Lequesne et al developed an index of severity for osteoarthritis for the knee which
      can be used to assess the effectiveness of therapeutic interventions. Unlike the earlier
      studies, we will use the Lequesne Functional Index (LFI) to assess the extent of joint health
      degeneration. In relation to OA, elevated levels of hs-CRP have been correlated with symptoms
      of joint pain and stiffness. Hence, we decided to analyze the hs-crp levels as one of the
      secondary objectives. Also, the rescue medication consumption has been limited to lower per
      day consumption compared to earlier studies to avoid the placebo effect influence on the
      study results. The efficacy of the IP in sustaining the pain relieving effect will be
      analyzed on day 35, i.e. one week after the end of the treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo-controlled, parallel group study.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: WOMAC pain score.
time frame: 28 days
description: • Change in terms of percentage reduction of joint pain from baseline to Day 28 during daily life activities assessed by WOMAC pain score.
measure: WOMAC stiffness score
time frame: 28 days
description: Change in terms of percentage reduction of joint pain from baseline to Day 28 joint stiffness as assessed by WOMAC stiffness score.
measure: WOMAC physical performance score.
time frame: 28 days
description: Change in terms of percentage reduction of joint pain from baseline to Day 28 in physical performance during daily life activities as assessed by WOMAC physical performance score.
measure: Lequesne Functional Index
time frame: 28 days
description: % reduction in joint degradation process as from baseline to Day 28 as assessed by Lequesne Functional Index
measure: Serum hs-CRP levels.
time frame: 28 days
description: % reduction in joint pain marker from baseline to Day 28 as assessed by serum hs-CRP levels.
measure: BMI
time frame: 28 days
description: % change in joint degradation related risk factor from baseline to Day 28 as assessed by BMI.
measure: % responders
time frame: 28 days
description: Comparison of uniformity of positive pain relieving individual response as assessed by % responders with ≥ 17% reduction in WOMAC pain score at Day 28.
measure: Rescue medication consumption
time frame: 28 days
description: Comparison of alternate analgesic therapy requirement as assessed by number of rescue medication consumption during the study.
measure: Sustained effect
time frame: 35 days
description: • To assess the sustained drug free period as assessed by WOMAC pain score joint pain at Day 35 as compared to Day 28.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
arm group label: Active
arm group type: Active Comparator
description: Lanconone(R)
intervention type: Dietary Supplement
intervention name: Lanconone
description: . Lanconone® is a joint pain supplement containing natural herbs such as Shyonak, Ashwagandha, Shunthi, Guggul, Chopchini, Rasna and Shallaki in therapeutic quantities and documented in the ancient scriptures as pain relievers.
arm group label: Active
intervention type: Other
intervention name: Placebo
description: Microcrystalline cellulose
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shalini Srivastava, MD
role: Study Director
affiliation: Enovate Biolife Pvt Ltd
facility: 
facility: 
facility: 
country: India
citation: Girandola RN, Srivastava S, Loullis CC. A clinical trial comparing Lanconone(R) with ibuprofen for rapid relief in acute joint pain. Trials. 2016 Apr 6;17:189. doi: 10.1186/s13063-016-1268-6.
PMID: 27052991
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided