Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT03610594
Status:
UNKNOWN
Last Update Posted:
2018-10-12
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-11', 'studyFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological Well-being', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Measured by MacArthur Health and Behavior Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Behavior', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Measured by Child Behavior Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological', 'Behavior']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children from 8 years to 12 years of age\n* Parents agreed to informed consent\n\nExclusion Criteria:\n\n* Physical disabilities\n* Diagnosed Mental or behavioural disorder\n* Practicing other exercise, physical trainings or yoga'}, 'identificationModule': {'nctId': 'NCT03610594', 'briefTitle': 'Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children', 'organization': {'class': 'OTHER', 'fullName': 'NMP Medical Research Institute'}, 'officialTitle': 'Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children: Randomised Wait- List Control Trial', 'orgStudyIdInfo': {'id': 'STVS 023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'kalaripayattu', 'description': 'The experimental groups will treated with kalaripayattu exercises for the period of 12 weeks', 'interventionNames': ['Other: Kalaripayattu']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list control', 'description': 'Control group will not be given any intervention. After the treatment period is over, all the subjects will be given Kalaripayattu training.'}], 'interventions': [{'name': 'Kalaripayattu', 'type': 'OTHER', 'description': 'Combination of Exercise, breathing, meditation, combat practices', 'armGroupLabels': ['kalaripayattu']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'NMP Medical Reserach Institute', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'overallOfficials': [{'name': 'Neha sharma, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Warwick Research Services'}, {'name': 'Ravishankar Ramanathan, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swamigal Trust for Vedic Studies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NMP Medical Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Warwick Research Services', 'class': 'OTHER'}, {'name': 'Swamigal Trust for Vedic Science, India', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}