PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 12:24:16 GMT)

CTRI Number CTRI/2020/03/024168 [Registered on: 23/03/2020] - Trial Registered Prospectively Last Modified On 20/03/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Ayurveda Study Design Single Arm Trial Public Title of Study A study to assess the effect of balachaturbhadra arka in the management og grade I&II under nutrition in Under five children attending anaganawadi Scientific Title of AN INTERVENTIONAL STUDY TO ASSESS THE AUGMENTING EFFECT OF Study BALACHATURBADRA ARKA IN GRADE I & II UNDERNUTRITION IN CHILDREN ATTENDING ANGANWADI Secondary IDs if Any Secondary ID Identifier - NIL NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name DR B G KULKARNI Trial Coordinator (multi-center study) Designation PRINCIPAL/ MEDICAL SUPERITENDENT Affiliation Parul Institute of Ayurved and Research, Address Parul Institute of Ayurved and Research, Ishwarapura, P.O Limda, Tal Waghodia, , medical teaching staff quarters, 801 , Parul university campusP.O Limda, Tal Waghodia, Vadodara, Vadodara 391760 Phone 9480302935 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Prasanna Mathad Query) Designation Professor Affiliation Parul Institute of Ayurved and Research Address Parul Institute of Ayurved and Research, Ishwarapura, P.O Limda, Tal Waghodia, Vadodara, Medical teaching staff quarter, 505, parul university campus P.O Limda, Tal Waghodia, Vadodara, Vadodara GUJARAT 391760 India Phone 9448630285 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Prasanna Mathad Designation Professor Affiliation Parul Institute of Ayurved and Research Address Parul Institute of Ayurved and Research, Ishwarapura, P.O Limda,

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Tal Waghodia, Vadodara, Medical teaching staff quarters, 505, parul university campus, P.O Limda, Tal Waghodia, Vadodara, Vadodara GUJARAT 391760 India Phone 9448630285 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Center of Research for Development, Parul University Primary Sponsor Primary Sponsor Details Name Center of Research for Development Address Parul University P.O Limda,Tal.Waghodia, Vadodara, Gujarat Type of Sponsor Other [Research Cell of private University] Details of Secondary Name Address Sponsor Nil Nil Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr prasanna mathad khemdas ayurved Parul Institute of 9448630285 Hospital Ayurved and Research, Ishwarapura, P.O prasannamathad@gmai Limda, Tal Waghodia, l.com Vadodara, Vadodara GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? PIARIECHR Approved 22/10/2019 No Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Patients Body mass index (BMI) pediatric Intervention / Type Name Details Comparator Agent Intervention BALACHATURBHADRA ARKA 5ML TWICE A DAY BEFORE 10 MINUTES OF FOOD. Comparator Agent nil nil Inclusion Criteria Inclusion Criteria Age From 3.00 Year(s) Age To 5.00 Year(s) Gender Both Details The children going to anganawadi who were having underweight less than 60-80% of expected weight for age. Exclusion Criteria Exclusion Criteria Details Endocrinal disorders, congenital abnormalities, known case of metabollic disorder

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Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints to evaluate the efficacy of balachaturbhadra arka assessment mainly on 45th day and 90th day on the basis of ABCDQ ASSESSMENT. To assess Antropametrical, biological, clinical, diet and quality of life in under nourished children Secondary Outcome Outcome Timepoints Nil Nil Target Sample Size Total Sample Size=100 Sample Size from India=100 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 2 Date of First 23/03/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details is after the complete completion of study Brief Summary A STUDY TO ASSESS THE EFFECT OF BALACHATURBHADRA ARKA IN THE MANAGEMENT OF GRADE I&II UNDER NUTRITION IN UNDER FIVE CHILDREN ATTENDING ANGANAWADI, TO BE CONDUCTED IN KHEMADAS AYURVED HOSPITAL A TEACHING HOSPITAL OF PARUL INSTITUTE OF AYURVED AND RESEARCH, ISHWARAPURA, VADODARA,INDIA, FOR THE PERIOD OF 18 MONTHS IN 100 PATIENTS. THE ABCDQ ASSESSMENT IS USED TO ASSESS THE NUTRITIONAL STATUS OF CHILDREN BEFORE AND AFTER THE INTERVENTION OF TREATMENT

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