| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Children |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Other 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. |