Clinical study to evaluate the Immunomodulatory effect of swarnaprashan in children under 5 years of age
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Madan Mohan Malviya Government Ayurved College Udaipur
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Relief from recurrent infection
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Month(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Relief from recurrent infection
Time Frame: 28 days
and increase immunity
Time Frame: 28 days
Secondary Outcomes
- compare the immunomodulatory effect of both group(28 days)
Investigators
Dr Saloni Ranawat
Madan Mohan Malviya Government Ayurved College