PsychologicalNCT03610594
Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children
A study testing Kalaripayattu in people with Psychological and Behavior, run by NMP Medical Research Institute at 1 site in India.
Trial summary
Kalaripayattu is an ancient martial art of India which has been practiced for centuries. It is mentioned in Vedic litrature of Ayurveda,Dhanurveda and Yoga. The main elements of Kalaripayattu include training in physical, combat, breathing exercises, higher form of meditation and specific class of medical treatments. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological, Behavior
- What is being tested?
- Kalaripayattu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2018to 1 Sep 2019
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from 8 years to 12 years of age
- Parents agreed to informed consent
Who cannot join
- Physical disabilities
- Diagnosed Mental or behavioural disorder
- Practicing other exercise, physical trainings or yoga
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children: Randomised Wait- List Control Trial
Kalaripayattu is an ancient martial art of India which has been practiced for centuries. It is mentioned in Vedic litrature of Ayurveda,Dhanurveda and Yoga. The main elements of Kalaripayattu include training in physical, combat, breathing exercises, higher form of meditation and specific class of medical treatments. The purpose of the experimental study is to determine the effect of kalaripayattu on psychological well-being and behaviour in children.
- Conditions
- Psychological, Behavior
- Being tested
- Kalaripayattu
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KalaripayattuOther
Combination of Exercise, breathing, meditation, combat practices
| Study group | Role | What they receive |
|---|---|---|
| kalaripayattu | Experimental | The experimental groups will treated with kalaripayattu exercises for the period of 12 weeks Receives: Other: Kalaripayattu |
| Wait list control | No intervention | Control group will not be given any intervention. After the treatment period is over, all the subjects will be given Kalaripayattu training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Well-being
Measured by MacArthur Health and Behavior Questionnaire
Measured: Change from baseline to 12 weeks
Secondary outcomes (1)
Behavior
Measured by Child Behavior Scale
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 posted1 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Swamigal Trust for Vedic Science, India
- Responsible party
- Sponsor
- Investigators
- Neha sharma, PhD, Study director, Warwick Research ServicesRavishankar Ramanathan, BA, Principal investigator, Swamigal Trust for Vedic Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610594
- Sponsor's protocol ID
- STVS 023
- Status last verified
- Oct 2018
- First submitted
- 26 Jul 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children: Randomised Wait- List Control Trial
- ClinicalTrials.gov ID
- NCT03610594
- Acronym / sponsor ID
- STVS 023
- Conditions
- Psychological, Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Swamigal Trust for Vedic Science, India
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 1 Aug 2018 (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.
Kalaripayattu is an ancient martial art of India which has been practiced for centuries. It is mentioned in Vedic litrature of Ayurveda,Dhanurveda and Yoga. The main elements of Kalaripayattu include training in physical, combat, breathing exercises, higher form of meditation and specific class of medical treatments. The purpose of the experimental study is to determine the effect of kalaripayattu on psychological well-being and behaviour in children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kalaripayattu | Experimental | Other: KalaripayattuThe experimental groups will treated with kalaripayattu exercises for the period of 12 weeks |
| Wait list control | No intervention | –Control group will not be given any intervention. After the treatment period is over, all the subjects will be given Kalaripayattu training. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children from 8 years to 12 years of age
- Parents agreed to informed consent
Key exclusion criteria (3 listed)
- Physical disabilities
- Diagnosed Mental or behavioural disorder
- Practicing other exercise, physical trainings or yoga
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 |
|---|---|---|
| KalaripayattuCombination of Exercise, breathing, meditation, combat practices | Other | kalaripayattu |
Primary outcome
Psychological Well-being
Time frame: Change from baseline to 12 weeks
Measured by MacArthur Health and Behavior Questionnaire
1 secondary outcome
Behavior
Time frame: Change from baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
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 study director
Warwick Research Services
Ravishankar Ramanathan, BA principal investigator
Swamigal Trust for Vedic Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kalaripayattu in people with Psychological and Behavior, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Oct 2018. 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?
Results are not available in the source record.
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?
Psychological Well-being (time frame: Change from baseline to 12 weeks). 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 12 Oct 2018.