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CTRI Number  CTRI/2025/02/080223 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Scientific Exploration of Saraswata Ghrita Efficacy in Enhancing Memory in School Going Children 
Scientific Title of Study   Scientific Validation and Clinical Study on Saraswata Ghrita to Boost Memory in School Going Children WSR Masamatra Prayogena Shrutamatrantu Dharayet 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Tatpalliwar 
Designation  MD Scholar 
Affiliation  Post Graduate Institute of Ayurveda Jodhpur 
Address  PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India Jodhpur RAJASTHAN 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  9763066963  
Fax    
Email  rohittatpalliwar3007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Harish Kumar Singhal 
Designation  Professor & HOD 
Affiliation  Post Graduate Institute of Ayurveda Jodhpur 
Address  Room no 155 PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India Jodhpur RAJASTHAN 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  8619892143  
Fax    
Email  ayurharish14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Harish Kumar Singhal 
Designation  Professor & HOD 
Affiliation  Post Graduate Institute of Ayurveda Jodhpur 
Address  Room no 155 PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India Jodhpur RAJASTHAN 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  8619892143  
Fax    
Email  ayurharish14@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037 Rajasthan INDIA 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved DSRRAU Jodhpur 
Address  PG Department of Kaumarbhritya Post Graduate Institute of Ayurved DSRRAU Jodhpur 342037 Rajasthan INDIA 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohit Tatpalliwar  Post Graduate Institute of Ayurved DSRRAU Jodhpur  PG Department of Kaumarbhritya Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 9763066963

rohittatpalliwar3007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Post Graduate Institute of Ayurved  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children with average memory level (as per PGI memory scale score between 40-60 / 100) and normal IQ level. Children who are physically and mentally healthy will be considered. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Saraswata Ghrita, Reference: Chapter no.66 ,Rasayan Adhikar, Chakradutta Samhita , Route: Oral, Dosage Form: Ghrita, Dose: 16(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1. Children between age group of 6 to 13 years of both sexes.
2. Children with average memory level (as per PGI memory scale score between 40-60 / 100) and normal IQ level.
3. Children who are physically and mentally healthy will be considered in the study.
 
 
ExclusionCriteria 
Details  1. Children below 6 year & above 13 years of age.
2. Children with systemic disorder like GIT disorders, neurological disorders etc.
3. Children with learning disorders.
4. Children having mental illness such as schizophrenia, epilepsy etc.
5. Children having mental retardation due to any genetic inheritance.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Saraswata Ghrita to boost memory as “ Masamatra Prayogena Shrutamatrantu Dharayet ” in school going children.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Pharmaceutical study of Saraswata Ghrita.
To enhance intelligent quotient in children.
To evaluate the efficacy of Saraswata Ghrita in improving attention span.
To study the concept of smriti and memory.
 		 30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   07/04/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

1.     No of children - 60

2.   Age of Patients - 6 -13 year

3.   Name of Drug - Saraswata Ghrita

4.   Dose - Dose will be calculated as per Young formula. The standard dose of Ghrita will  be 1 Pal as per Acharya Sharangdhara. It will be given in two divided doses.

5.   Duration of Trial - 1 month

6.   Route - Oral 

7.   Type of Study :- Single arm open labelled study

8.   Follow up :- Every 15th day during study & after completion of study on 45th & 60th day 

 
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