- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813888
Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children
January 21, 2019 updated by: NMP Medical Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rajasthan
-
Jaipur, Rajasthan, India, 302019
- NMP Medical Research Institue
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arsha Vidya Group
After school, children joined regular sessions in Arsha Vidya study centre to practice, vedic chants, vedanta reading, yoga and group activities within the ashram.
|
Yoga, Vedic chants, Vedant sessions, Gita sessions and group activities within the Gurukulam (centre)
|
OTHER: Usual Activity Group
After school, control group were asked to conitue their usual routine.
|
Usual after school activities at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: Change from baseline to 12-week
|
Cognitive functions measured by the Cambridge Neuropsychological Test Automated Battery
|
Change from baseline to 12-week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behaviour
Time Frame: Change from Baseline to 12-weeks
|
Behaviour measured by the Behavior Rating Inventory of Executive Function
|
Change from Baseline to 12-weeks
|
Attention
Time Frame: Change from baseline to 12-weeks
|
Attention measured by the D2 Test of Attention
|
Change from baseline to 12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Puneet Sharma, Sarvatra International, Dubai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 21, 2017
Primary Completion (ACTUAL)
January 15, 2018
Study Completion (ACTUAL)
March 12, 2018
Study Registration Dates
First Submitted
January 21, 2019
First Submitted That Met QC Criteria
January 21, 2019
First Posted (ACTUAL)
January 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 21, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- NMP/ Arsha/0092
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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