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CTRI Number  CTRI/2021/05/033713 [Registered on: 21/05/2021] Trial Registered Prospectively
Last Modified On: 08/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [immunomodulatory effect]  
Study Design  Single Arm Study 
Public Title of Study   To study the effect of Swarnaprashan in reducing the frequency of illness in children by improving the immunity and increasing the body strength.  
Scientific Title of Study   Clinical Evaluation of Immunomodulatory Effect of Swarnaprashan in Children: A Prospective Open Label Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Sahadat Khan 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda, Jaipur, Rajasthan 
Address  PG department of kaumarbhritya National institute of ayurveda jaipur rajasthan
Vill. balakheda post anta dist. baran rajasthan 325202
Jaipur
RAJASTHAN
302002
India 
Phone  9166109123  
Fax    
Email  Shahadat1991khan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrNisha Kumari Ojha 
Designation  Associate Professor & HOD 
Affiliation  National Institute of Ayurveda Jaipur, Rajasthan 
Address  PG Department of Kaumarbhritya National Institute of Ayurveda Jaipur Rajasthan
PG Department of Kaumarbhritya National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India 
Phone  9468650449  
Fax    
Email  drnishaojha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrNisha Kumari Ojha 
Designation  Associate Professor & HOD 
Affiliation  National Institute of Ayurveda, Jaipur, Rajasthan 
Address  PG Department of Kaumarbhritya National Institute of Ayurveda Jaipur Rajasthan
PG Department of Kaumarbhritya National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India 
Phone  9468650449  
Fax    
Email  drnishaojha@gmail.com  
 
Source of Monetary or Material Support  
Nageshwar pharmacy , NIA, Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur Rajasthan 
Address  pg department of kaumarbhritya National institute of ayurveda jaipur rajasthan 
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 
Sahadat Khan  National Institute of Ayurveda, Jaipur  Madhav vilas palace, Amer road jaipur
Jaipur
RAJASTHAN 
9166109123

Shahadat1991khan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D839||Common variable immunodeficiency,unspecified. Ayurveda Condition: OJA-VYAPAT,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  SwarnaPrashan  Swarnaprashan will be prescribed in 1 drop/kg /day(0.2-0.3mg Swarna bhasma per drop) for 8 weeks 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Children aged from 2-5 years of either sex
2. Childern with recurrent respiratory infections
3. Childern with recurrent G.I.T. diseases
4. Children with recurrent fever
5. Children with recuurent episodes of diarrhea
6. Children with other recurrent diseases 
 
ExclusionCriteria 
Details  1. Subjects suffering from major systemic illness necessitating long term treatment
2. Subjects with evidence of malignancy
3. Subject with aspartate amino transferase(AST) and or alanine amino transferase ALT>3 Times of the upper normal limit and renal dysfunction (Sr. creatinine >1.2mg/dl), uncontrolled pulmonary dysfunction( asthmatic and COPD patients) .
4. Co-morbidity like TB, UTI and bleeding disorders etc
5. Congenital anomalies and hereditary disease.
6. Pulmonary or abdominal tuberculosis.
7. H/O hypersensitivity to any of the trial drug or any of its ingredients.
8. Subjects who have completed participation in any other clinical trial during the past six months.
9. Any contraindications mentioned for Lehan karma in Kashyap Samhita. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Observe the Immunomodulatory effect of Swarnaprashan.  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Morbidity rate in children.  8 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
02/07/2021 
Date of Study Completion (India) 18/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
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 infections because their immune system is less developed. This has long adverse effect on child’s physical and mental growth. The global burden of child death is call for urgent and concerted action to further improve the survival chances of the world’s children. A baby’s immune system is not fully developed thus, more prone to infections than in adults. Thus a healthy immune system is very important for the maintenance of health and prevention of diseases. In children the major causes of childhood morbidity and mortality are various preventable infections. Though National vaccination schedule is implicated, mortality rate in India is still high. From the first day of life vaccination schedule is started but these vaccine do not protect the child from the disease by bacterial infection, viral infections and primary, secondary immunodeficiency syndrome. If proper precautions are taken, many of these diseases can be prevented. The under five mortality rate for the world is 40.8 death and Infant mortality rate in India is 36.6 death according to the world bank and the world health organization. 5.6 million children under five age died in 2006, 15000 everyday.1,2,3

The leading cause of death among children under age five included4-

 Preterm birth complication 18%·

 Intra-partum related events 13%·

 Pneumonia 15%·

 Diarrhea 8%·

 Neonatal sepsis 7%·

 Malaria 5%·

 Malnutrition and under nutrition·

In 2017, an estimated 6.3 million children and adolescents died, mostly from preventable cause and 85% of the 6.3 million deaths in 2017 occurring in the first five years of life5.

Parents reported symptoms suggestive of a history of Eczema in 10.3%, Rhinitis in 24.2% and Asthma in 23.6% of children. Overall 43.7% of children had symptoms suggestive of at least on allergic disorder, with a substantial minority manifesting symptoms indicative of co-morbid allergic disorder. 6

Ayurveda, presents different concept of immunity( vyadhikshmatva) which is internal strength or bala, that comes from the doshas being in balance, digestion and metabolism functioning normally and the tissues growing properly. Vyadhikshmatva is the inherent or an acquired

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capacity of the body in preventing a disease or in modifying the course on an already manifested disease to a milder extent.

Kashyap Samhita is an oldest text book of Kaumarbhritya written by Vridhajeevaka. Kaumarbhritya is one of leading branch of Ayurveda that dealing with mother and child health care. Kashyapa has described the concept of Lehan in which the practice of administration of processed gold is mentioned as Swarnaprashan.

Acharya have mentioned many benefits of Swarnaprashan-

• Medha vardhan- Intellect promoting

• Agni vardhan- Improvement in digestion

• Bala vardhan- Strength promoting

• Ayushyam- Improvement in life expectancy

• Mangal, Punya- Auspicious

• Vrishya- Aphrodisiac

• Varnaya- Improvement in complexion and skin texture

• Grahapaham- Protection from evil spirits and microorganisms

• Shrutdhara- Capable of grasping even on listening

Most of the classics mentioned different Lehanas for the children mainly they are the combination of Swarna, Ghrita and Madhu. Charak Samhita mentioned only mixture of Ghrita and Madhu.

 

 
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