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CTRI Number  CTRI/2023/04/052105 [Registered on: 28/04/2023] Trial Registered Prospectively
Last Modified On: 19/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the IQ enhancing effect of Swarnprashana in Preschool Children 
Scientific Title of Study   Single arm open labelled trial to evaluate the efficacy of Swarnprashana in reference of ‘Maasat Param Medhavi’ in Preschool Children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruti 
Designation  MD Scholar 
Affiliation  Shri Krishna Ayurvedic College Kurukshetra 
Address  Room Number 99, Department of Kaumarbhritya, Shri Krishna Government Ayurvedic College Kurukshetra Sector 8, Umari Road Kurukshetra, Haryana

Kurukshetra
HARYANA
136118
India 
Phone  7069156655  
Fax    
Email  bharmauriashrutti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Kataria 
Designation  Associate Profesor 
Affiliation  Shri Krishna Ayurvedic College Kurukshetra 
Address  Room Number 99, Department of Kaumarbhritya, Shri Krishna Government Ayurvedic College Kurukshetra Sector 8, Umari Road Kurukshetra, Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9034001230  
Fax    
Email  dramitkataria@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Kataria 
Designation  Associate Profesor 
Affiliation  Shri Krishna Ayurvedic College Kurukshetra 
Address  Room Number 99, Department of Kaumarbhritya, Shri Krishna Government Ayurvedic College Kurukshetra Sector 8, Umari Road Kurukshetra, Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9034001230  
Fax    
Email  dramitkataria@rediffmail.com  
 
Source of Monetary or Material Support  
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra, Haryana, 136118 
 
Primary Sponsor  
Name  Shri Krishna Govt Ayurvedic College and Hospital Kurukshetra Haryana 
Address  Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector-8, Kurukshetra, Haryana, 136118  
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 Amit Kataria  Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra   Depatment of Kaumarbhritya, Shri Krishna Govt. Ayurvedic College and Hospital, Umri road, Sector-8, Kurukshetra, Haryana, 136118 Kurukshetra HARYANA
Kurukshetra
HARYANA 
9034001230

dramitkataria@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Krishna Ayush University Kurukshetra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Appropriately healthy preschool children  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Swarnaprashna, Reference: Kashypa Samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Dose of of Swarnaprashna will be calculated by using to the Clarks formula according to dose of swarna bhashma. The basis of swarna bhasham dose will Rastangini
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Female 
Details  1.Healthy children of either sex belonging to age group 3 to 6 years.
2.Parents willing their children to participate in the trial.
 
 
ExclusionCriteria 
Details  1.Age below 3 years and above 6 years.
2.All congenital anomalies and all hereditary diseases.
3.Children with acute and chronic systemic infectious diseases, metabolic disorders, learning disability, Mental Retardation, Cerebral palsy.
4.All the contraindications of lehana mentioned in Kashyapa Samhita like - Jwara, Agnimandya, Atisara etc.
5. Subject having known history of allergy from trial drug ingredients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intelligence Quotient by Binet Kamat Test adaptation of the Stanford -Binet Test   0 day and 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the general growth parameters of healthy pre-school going children viz. height, weight, MUAC, head circumference, chest circumference and BMI.  0 day and 45th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/07/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/01/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

v  Swarnaprashana prepared in this study demonstrates a range of beneficial properties including antioxidant, anti-inflammatory, antimicrobial, immunomodulatory, nootropic properties. These effects contribute to promote immunity, growth and development, ultimately enhancing overall health in children.

v  All the ingredients of this herbomineral prepration Swarnaprashana exhibits nootropic effect and hence lead to improvement in IQ scores of the preschool children when administered for continuous one month duration in the present study and further stating the fact of “Maasat Param Medhavi” as described in the ancient text by Acharya Kashyapa.

v  Total effect of therapy showed varied results on IQ score improvement data among participants.

v  Moderate Improvement: The majority of participants experienced moderate gains, with 42 individuals increasing their IQ scores by 1-2 points.

v  Significant Improvement: A smaller group of 7 participants achieved significant improvements of more than 3 points, indicating substantial cognitive enhancement.

v  Mild Improvement: Mild improvement was noted in 7 cases.

v  Marked Improvement: Four participants demonstrated marked improvement, with increases of 2-3 points.

v  Interestingly, none of the participants reported no improvement at all.

v  There was a statistically significant increase in haemoglobin levels from 11.35 ± 1.07 gm% to 11.88 ± 1.09 gm% (p < 0.0001). This indicates a highly significant improvement in hemoglobin levels post-trial.


 
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