<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/NCT04504305</url>
  </required_header>
  <id_info>
    <org_study_id>VC/190403/NUEROPAWAY/PN</org_study_id>
    <nct_id>NCT04504305</nct_id>
  </id_info>
  <brief_title>To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Investigational Product Nerve Support Formula on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.</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>
      this study is to be carried out to examine the effect of Investigation product on diabetic&#xD;
      individuals suffering from diabetic neuropathic pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">February 18, 2021</completion_date>
  <primary_completion_date type="Actual">January 7, 2021</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.</measure>
    <time_frame>42 days</time_frame>
    <description>pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.</measure>
    <time_frame>42 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.</measure>
    <time_frame>42 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .</measure>
    <time_frame>42 Days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Diabetic Neuropathies</condition>
  <condition>Insomnia Due to Medical Condition</condition>
  <arm_group>
    <arm_group_label>Neuropaway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Microcystalline cellulose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NeuropAWAY</intervention_name>
    <description>2 capsules thrice daily to be taken half an hour prior to meal.</description>
    <arm_group_label>Neuropaway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Microcystalline cellulose</intervention_name>
    <description>2 capsules thrice daily to be taken half an hour prior to meal.</description>
    <arm_group_label>Microcystalline cellulose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Females aged ≥ 40 and ≤ 65 years of age.&#xD;
&#xD;
          -  Participants with primary complaints of lower limb pain.&#xD;
&#xD;
          -  History of Diabetes mellitus for more than one year.&#xD;
&#xD;
          -  Participants with HbA1c ≥ 7.1 and ≤ 9.5%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with severe cardiac disease&#xD;
&#xD;
          -  Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood&#xD;
             pressure ≥ 85.&#xD;
&#xD;
          -  Type II DM with history of foot ulcers in the last six months prior to the study&#xD;
&#xD;
          -  History of nerve damage not due to Painful Diabetic Neuropathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stress Test Clinic</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400047</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shantaee</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400067</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Diabetic Neuropathies</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04504305
org study id: VC/190403/NUEROPAWAY/PN
nct id: NCT04504305
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
this study is to be carried out to examine the effect of Investigation product on diabetic
      individuals suffering from diabetic neuropathic pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.
time frame: 42 days
description: pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain
measure: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.
time frame: 42 days
measure: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.
time frame: 42 Days
measure: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .
time frame: 42 Days
arm group label: Neuropaway
arm group type: Active Comparator
arm group label: Microcystalline cellulose
arm group type: Placebo Comparator
intervention type: Other
intervention name: NeuropAWAY
description: 2 capsules thrice daily to be taken half an hour prior to meal.
arm group label: Neuropaway
intervention type: Other
intervention name: Microcystalline cellulose
description: 2 capsules thrice daily to be taken half an hour prior to meal.
arm group label: Microcystalline cellulose
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Diabetic Neuropathies
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2