Cognitive ChangeNCT03813888
Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children
A study testing Arsha Vidya chldren's Group and Usual Activity group in people with Cognitive Change, run by NMP Medical Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Arsha Vidya chldren's Group and Usual Activity group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 21 Mar 2017to 12 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cognitive Change
- Being tested
- Arsha Vidya chldren's Group, Usual Activity group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsha Vidya chldren's GroupOther
Yoga, Vedic chants, Vedant sessions, Gita sessions and group activities within the Gurukulam (centre)
Usual Activity groupOther
Usual after school activities at home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Arsha Vidya chldren's Group |
| Usual Activity Group | Other | After school, control group were asked to conitue their usual routine. Receives: Other: Usual Activity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Cognitive functions measured by the Cambridge Neuropsychological Test Automated Battery
Measured: Change from baseline to 12-week
Secondary outcomes (2)
Behaviour
Behaviour measured by the Behavior Rating Inventory of Executive Function
Measured: Change from Baseline to 12-weeks
Attention
Attention measured by the D2 Test of Attention
Measured: Change from baseline to 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start21 Mar 2017
- Primary completion15 Jan 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Arsha Vidya Study Centre, Tamilnadu, India
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Warwick Research ServicesPuneet Sharma, Study director, Sarvatra International, DubaiBuddhatmananda Saraswati, Study chair, Arsha Vidya Study Centre, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813888
- Sponsor's protocol ID
- NMP/ Arsha/0092
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children
- ClinicalTrials.gov ID
- NCT03813888
- Acronym / sponsor ID
- NMP/ Arsha/0092
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Arsha Vidya Study Centre, Tamilnadu, India
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arsha Vidya Group | Experimental | Other: Arsha Vidya chldren's GroupAfter school, children joined regular sessions in Arsha Vidya study centre to practice, vedic chants, vedanta reading, yoga and group activities within the ashram. |
| Usual Activity Group | Other | Other: Usual Activity groupAfter school, control group were asked to conitue their usual routine. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arsha Vidya chldren's GroupYoga, Vedic chants, Vedant sessions, Gita sessions and group activities within the Gurukulam (centre) | Other | Arsha Vidya Group |
| Usual Activity groupUsual after school activities at home. | Other | Usual Activity Group |
Primary outcome
Cognitive function
Time frame: Change from baseline to 12-week
Cognitive functions measured by the Cambridge Neuropsychological Test Automated Battery
2 secondary outcomes
Behaviour
Time frame: Change from Baseline to 12-weeks
Attention
Time frame: Change from baseline to 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
Related trials for Cognitive Change
Active, not recruiting
Improving Emotional Wellbeing of University Students: Anxiety Management
Anxiety
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
RecruitingObservational study
Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy
Lymphoma Receiving CAR-T Therapy
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Enrolling by invitation
Brain Heath Service for Prevention of AD
Alzheimer, Cognitive Unimpaired
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, PhD principal investigator
Warwick Research Services
Puneet Sharma study director
Sarvatra International, Dubai
Buddhatmananda Saraswati study chair
Arsha Vidya Study Centre, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arsha Vidya chldren's Group and Usual Activity group in people with Cognitive Change, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: Change from baseline to 12-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.