NCT03813888

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

January 21, 2019

Last Update Submit

January 21, 2019

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Cognitive functions measured by the Cambridge Neuropsychological Test Automated Battery

    Change from baseline to 12-week

Secondary Outcomes (2)

  • Behaviour

    Change from Baseline to 12-weeks

  • Attention

    Change from baseline to 12-weeks

Study Arms (2)

Arsha Vidya Group

EXPERIMENTAL

After school, children joined regular sessions in Arsha Vidya study centre to practice, vedic chants, vedanta reading, yoga and group activities within the ashram.

Other: Arsha Vidya chldren's Group

Usual Activity Group

OTHER

After school, control group were asked to conitue their usual routine.

Other: Usual Activity group

Interventions

Arsha Vidya chldren's GroupOTHER

Yoga, Vedic chants, Vedant sessions, Gita sessions and group activities within the Gurukulam (centre)

Arsha Vidya Group
Usual Activity groupOTHER

Usual after school activities at home.

Usual Activity Group

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Be 8 - 11 years of age at the start of the intervention
  • Healthy Children
  • Not start new activity within the intervention period
  • Parental conset
  • Parents to allow and participate where needed in intervention

You may not qualify if:

  • Serious chronic illnesses and diseases
  • Diagnosed with any psychiatric illness
  • Intake of medication that may affect study outcomes
  • not able to continue for 12-weeks of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Research Institue

Jaipur, Rajasthan, 302019, India

Location

Study Officials

  • Neha Sharma, PhD

    Warwick Research Services

    PRINCIPAL INVESTIGATOR

  • Puneet Sharma

    Sarvatra International, Dubai

    STUDY DIRECTOR

  • Buddhatmananda Saraswati

    Arsha Vidya Study Centre, India

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 23, 2019

Study Start

March 21, 2017

Primary Completion

January 15, 2018

Study Completion

March 12, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

IN(1)