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CTRI Number  CTRI/2021/09/036573 [Registered on: 16/09/2021] Trial Registered Prospectively
Last Modified On: 08/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial To study the effect of Ayurvedic interventions on improving under-five children in Devbhoomi Dwarka district of Gujarat, India. 
Scientific Title of Study   Documenting impact of Ayurvedic intervention to improve the nutritional status of under five children and adolescents in Devbhoomi Dwarka distric, Gujarat, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Falgun Patel 
Designation  I/c deputy Director (Training & Reasearch) 
Affiliation  Govt. of Gujarat 
Address  Directorate Ayush, Second floor,Block-1, Jivraj Mehta Bhavan, Gandhinagar

Gandhinagar
GUJARAT
382010
India 
Phone    
Fax    
Email  ddayushtraining@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Shital Bhagiya 
Designation  Lecturer  
Affiliation  Govt. of Gujarat 
Address  Department of Panchakarma, State model Ayurveda College, Kolavada

Gandhinagar
GUJARAT
382028
India 
Phone    
Fax    
Email  shital1811@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jimeet Soni 
Designation  Research Associate 
Affiliation  Indian Institute of Public health 
Address  Indian Institute of Public health Gandhinagar, opp- Air force head quarter, palaj road, lekavada cross road, Gandhinagr

Gandhinagar
GUJARAT
382042
India 
Phone    
Fax    
Email  jimeetsoni9@gmail.com  
 
Source of Monetary or Material Support  
Govt. Ayurved pharmacy Rajpipla, Vadiya Palace Campus, Rajpipla , Gujarat 
 
Primary Sponsor  
Name  Dr Bhavna Patel Director Ayush 
Address  Directorate Ayush, Second Floor, Block-1 , Jivraj Mehta Bhavan, Gandhinagar. 
Type of Sponsor  Other [Govt. of Gujarat] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Saxena  Bhanvad   Indian Institute of Public health Gandhinagar, opp- Air force head quarter, palaj road, lekavada cross road, Gandhinagr.
Jamnagar
GUJARAT 		 9327396717

ddeepak72@iiphg.com 
Dr Deepak Saxena  OKHA MANDAL BLOCK  Indian Institute of Public health Gandhinagar, opp- Air force head quarter, palaj road, lekavada cross road, Gandhinagr.
Jamnagar
GUJARAT 		 9327396717

ddeepak72@iiphg.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Institute of Public Health  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E649||Sequelae of unspecified nutritional deficiency. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Shishu Bheshaj Granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 15(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information:
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Parents willing to give consent
Child with no morbid condition
 
 
ExclusionCriteria 
Details  Parents not giving consent
Child having any morbid condition
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Morbidity due to malnutrition disease
Weight gain
 		 Baseline, 3 months, 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in stunting and malnutrition status time
Improvement in diet and hunger

 		 6 month 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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   N/A 
Date of First Enrollment (India)   17/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The proposed study will be done in below mentioned phase.

 

Phase 1: The first phase will be preparatory one, includes round tables of experts of Ayurveda, Nutritionists and Epidemiologists to identify available Ayurveda intervention. This phase will also include identification of taluka with a higher prevalence of taluka stratified as per geographical boundaries. Children with severe malnutrition or severely underweight will be eligible for Ayurveda intervention.

Phase 2: Intervention phase

Second phase will involve baseline, intervention and midterm evaluation. The intervention will be conducted as a pre-post trial. The intervention will be executed through AYUSH medical officer posted at Primary Health Centre or at Ayurveda dispensaries in the supervision of D.A.O of concerned dist. Baseline and End line assessment of the nutritional status will also be done. Process documentation of the intervention and provision of midterm correction if needed. This process will also involve giving basic information to the participants about the malnutrition and also compliance of the intervention and reporting of side effects if any.

 
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