“An Experimental and Clinical Study on Swarnaprashan to Establish its Safety, antimicrobial activity and to Assess its Immunogenicity Effect after BCG Vaccinationâ€

It  will be  a singlearm open label Exploratory study including a totalof 30 patients of1-15years, irrespective of sex suffering with recurrent illness will be selected to assess themorbidity incidence during the study period. The Swarnaprashanwith Swarna bhasma -15mg, Madhu 2 mlof and 1 ml of Ghrita, will be given once a dayfor 1 month in early hours of morning (8 to 10 a.m.) after  gettingwritten informed consent from the parents. All the cases will be gathered  from the Kaumarbhritya - OPDor IPD; S.S. Hospital, IMS, BHU after assessing the following exclusion andinclusion criteria -

Inclusioncriteria:

a)Age between 1to 15 years

b)Having history of repeated respiratory or any other recurrent disorderirrespective to associated congenital, hereditary or developmental/nutritionaldisorders

c)Period of drug administration - asymptomatic Phase

ExclusionCriteria:

a)Neonates and infants <1year and 16 or more than 16 years

b)During any symptomatic illness

c)Suffering from degenerative neurological, IEM, etc.

Investigations:

Thefollowing investigations will be prescribed before and after 1month of drugadministration

CBC,GBP, LFT, RFT, ESR, Urine,stool Routine, Others–disease specific  like swab, urine, stool forculture and sensitivity, CT,MRI,X-ray

Follow up:: Thepatients will be called for follow up at an interval of 15 days for 3 monthsand as per the proforma theepisodes of respiratory or any other illness would be recorded.

Adverse effect:anyuntoward effects duringthe study willalso be recorded and treatment would be stopped in-between and the case wouldbe dropped and specific treatment will be given to relieve the symptoms.

Statistical Analysis:relevant statistical formula will be used for analysis of data.

Thenall Data shall be concluded after categorizing into particular specific part ofthe study as experimental, animal, clinical study with the reasoning on theparticular observation with statistical significance.

Fordata analysis SSPE software will be used in collaboration of Dep’t of Statistics.