<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/NCT03813888</url>
  </required_header>
  <id_info>
    <org_study_id>NMP/ Arsha/0092</org_study_id>
    <nct_id>NCT03813888</nct_id>
  </id_info>
  <brief_title>Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children</brief_title>
  <official_title>Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NMP Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Warwick Research Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arsha Vidya Study Centre, Tamilnadu, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NMP Medical Research Institute</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>
      The impact of Arsha Vidya program on cognitive performance was examined in elementary school&#xD;
      children. The study compares the effects of arsha vidya after school routine with usual after&#xD;
      school routine in healthy 8-11 year-old Indian children.&#xD;
&#xD;
      The main objective of the study is to investigate the effect on cognitive function, behaviour&#xD;
      and emotions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">March 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>Change from baseline to 12-week</time_frame>
    <description>Cognitive functions measured by the Cambridge Neuropsychological Test Automated Battery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behaviour</measure>
    <time_frame>Change from Baseline to 12-weeks</time_frame>
    <description>Behaviour measured by the Behavior Rating Inventory of Executive Function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention</measure>
    <time_frame>Change from baseline to 12-weeks</time_frame>
    <description>Attention measured by the D2 Test of Attention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Cognitive Change</condition>
  <arm_group>
    <arm_group_label>Arsha Vidya Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After school, children joined regular sessions in Arsha Vidya study centre to practice, vedic chants, vedanta reading, yoga and group activities within the ashram.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Activity Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After school, control group were asked to conitue their usual routine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arsha Vidya chldren's Group</intervention_name>
    <description>Yoga, Vedic chants, Vedant sessions, Gita sessions and group activities within the Gurukulam (centre)</description>
    <arm_group_label>Arsha Vidya Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Activity group</intervention_name>
    <description>Usual after school activities at home.</description>
    <arm_group_label>Usual Activity Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 8 - 11 years of age at the start of the intervention&#xD;
&#xD;
          -  Healthy Children&#xD;
&#xD;
          -  Not start new activity within the intervention period&#xD;
&#xD;
          -  Parental conset&#xD;
&#xD;
          -  Parents to allow and participate where needed in intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious chronic illnesses and diseases&#xD;
&#xD;
          -  Diagnosed with any psychiatric illness&#xD;
&#xD;
          -  Intake of medication that may affect study outcomes&#xD;
&#xD;
          -  not able to continue for 12-weeks of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neha Sharma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Warwick Research Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Puneet Sharma</last_name>
    <role>Study Director</role>
    <affiliation>Sarvatra International, Dubai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Buddhatmananda Saraswati</last_name>
    <role>Study Chair</role>
    <affiliation>Arsha Vidya Study Centre, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NMP Medical Research Institue</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302019</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03813888
org study id: NMP/ Arsha/0092
nct id: NCT03813888
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The impact of Arsha Vidya program on cognitive performance was examined in elementary school
      children. The study compares the effects of arsha vidya after school routine with usual after
      school routine in healthy 8-11 year-old Indian children.

      The main objective of the study is to investigate the effect on cognitive function, behaviour
      and emotions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cognitive function
time frame: Change from baseline to 12-week
description: Cognitive functions measured by the Cambridge Neuropsychological Test Automated Battery
measure: Behaviour
time frame: Change from Baseline to 12-weeks
description: Behaviour measured by the Behavior Rating Inventory of Executive Function
measure: Attention
time frame: Change from baseline to 12-weeks
description: Attention measured by the D2 Test of Attention
arm group label: Arsha Vidya Group
arm group type: Experimental
description: After school, children joined regular sessions in Arsha Vidya study centre to practice, vedic chants, vedanta reading, yoga and group activities within the ashram.
arm group label: Usual Activity Group
arm group type: Other
description: After school, control group were asked to conitue their usual routine.
intervention type: Other
intervention name: Arsha Vidya chldren's Group
description: Yoga, Vedic chants, Vedant sessions, Gita sessions and group activities within the Gurukulam (centre)
arm group label: Arsha Vidya Group
intervention type: Other
intervention name: Usual Activity group
description: Usual after school activities at home.
arm group label: Usual Activity Group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Neha Sharma, PhD
role: Principal Investigator
affiliation: Warwick Research Services
last name: Puneet Sharma
role: Study Director
affiliation: Sarvatra International, Dubai
last name: Buddhatmananda Saraswati
role: Study Chair
affiliation: Arsha Vidya Study Centre, India
facility: 
country: India
responsible party type: Sponsor