- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03610594
Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children
October 11, 2018 updated by: NMP Medical Research Institute
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
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
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Jaipur, Rajasthan, India
- NMP Medical Reserach Institute
-
-
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 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children from 8 years to 12 years of age
- Parents agreed to informed consent
Exclusion Criteria:
- Physical disabilities
- Diagnosed Mental or behavioural disorder
- Practicing other exercise, physical trainings or yoga
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: kalaripayattu
The experimental groups will treated with kalaripayattu exercises for the period of 12 weeks
|
Combination of Exercise, breathing, meditation, combat practices
|
|
No Intervention: Wait list control
Control group will not be given any intervention.
After the treatment period is over, all the subjects will be given Kalaripayattu training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Well-being
Time Frame: Change from baseline to 12 weeks
|
Measured by MacArthur Health and Behavior Questionnaire
|
Change from baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavior
Time Frame: Change from baseline to 12 weeks
|
Measured by Child Behavior Scale
|
Change from baseline to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ravishankar Ramanathan, BA, Swamigal Trust for Vedic Studies
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)
September 1, 2018
Primary Completion (Anticipated)
June 30, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
July 26, 2018
First Submitted That Met QC Criteria
July 26, 2018
First Posted (Actual)
August 1, 2018
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
October 11, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- STVS 023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.