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CTRI Number  CTRI/2025/04/084145 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the number of children effected with recurrent infection and effect of Ayurvedic compound Swarnaprashan increase immunity in children. Also to study the various factors responsible for the poor immunity  
Scientific Title of Study   Clinical study to evaluate the Immunomodulatory effect of swarnaprashan in children under 5 years of age 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saloni Ranawat 
Designation  MD Scholar 
Affiliation  Madan Mohan Malviya Government Ayurved College  
Address  P.G. Department of kaumarbhritya Madan Mohan Malviya Government Ayurved College, Rada ji choraha,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  6367462864  
Fax    
Email  saloniranawat18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ram Kumar 
Designation  Professor and Head of department 
Affiliation  Madan Mohan Malviya Government Ayurved College  
Address  P.G. Department of kaumarbhritya Madan Mohan Malviya Government Ayurved College, Rada ji choraha,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  8005857838  
Fax    
Email  drbhamuramkumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Ram Kumar 
Designation  Professor and Head of department 
Affiliation  Madan Mohan Malviya Government Ayurved College  
Address  P.G. Department of kaumarbhritya Madan Mohan Malviya Government Ayurved College, Rada ji choraha,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  8005857838  
Fax    
Email  drbhamuramkumar@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Government Ayurved College, Rada ji chouraha, district- Udaipur ,Rajasthan ,India pin code -313001  
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurved College Udaipur  
Address  Madan Mohan Malviya Government Ayurved College, Rada ji chouraha, district- Udaipur ,Rajasthan ,India pin code -313001  
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 Saloni Ranawat  Campus hospital, motichohatta hospital Udaipur, Rajasthan   Kaumarbhritya OPD no.4 in campus hospital and OPD no.3 in motichohatta hospital, Madan Mohan Malviya Government Ayurved College, Udaipur
Udaipur
RAJASTHAN 
6367462864

saloniranawat18@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Children  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Swarnaprashana , Reference: Kashyap samhita , Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: In group A swarnaprashana will be administered once daily in 06 month to 5 years old children for 28 days continue
2Comparator ArmDrugOther than Classical(1) Medicine Name: placebo drug ( madhu ), Reference: NA, Route: Oral, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: dose as per young and frieds formula administered route -oral
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children aged between 06 Month to 05 years of either sex.
Children with recurrent respiratory infections.
Children with recurrence of fever and other infection.
Children with recurrence of gastro intestinal infection.
Children delay with growth and development.
 
 
ExclusionCriteria 
Details  Children suffering from major systemic illness necessitating long term treatment.
Children with evidence of malignancy, genetic or congenital anomaly.
Co-morbidity like TB, UTI and bleeding disorders etc


 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief from recurrent infection
and increase immunity
 
28 days
 
 
Secondary Outcome  
Outcome  TimePoints 
compare the immunomodulatory effect of both group  28 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 2 
Date of First Enrollment (India)   01/07/2025 
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="4"
Days="15" 
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  

     Children are vulnerable to infection because their immune system less developed. The urgent need for collective action to enhance children’s survival rates worldwide parallels the critical importance of childhood growth and development. Early childhood development is complex, involving various dimensions such as physical, social, emotional and mental aspects. so many vaccines are available for infectious diseases and antibiotics are successful in fighting the infections but emergence of antibiotic resistance is a great challenge in the present era. Also, frequent use of antibiotics creates lot of side-effects which also adversely affect the growth and development of the child. Childhood is a fragile age and too many vaccine shots and antibiotics may result in dangerous side effects in children. There is a strong need to develop nonspecific immunity in children which help them to fight against recurrent infections. Modern medical science lacks adequate management strategies to prevent such recurrences and enhance the immune system. However, ancient literature, particularly the Kashyap Samhita, provides us with valuable insights into immunomodulatory practices like Swarnaprashan, aimed at preventing children from infections and promoting their physical and mental growth.


 
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