“A Clinical Study on Swarnaprashan to Establish its Safety in children suffering from recurrent infections"

Phase 3

Not yet recruiting

• Conditions: Acute upper respiratory infectionsof multiple and unspecified sites. Ayurveda Condition: repeated upper respiratory tract infections in children,

• Registration Number: CTRI/2021/09/036941
• Lead Sponsor: INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY

Brief Summary

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:

**T**hefollowing 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-10
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• a) Age between 1to 15 years b) Having history of repeated respiratory or any other recurrent disorder irrespective to associated congenital, hereditary or developmental/nutritional disorders c) Period of drug administration.
• asymptomatic Phase.

Exclusion Criteria

a) Neonates and infants <1year and 16 or more than 16 years b) During any symptomatic illness c) Suffering from degenerative neurological, IEM, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IMPROVEMENT IN immunity and overall health condition due to reduction in number of episodes of illness and safety of drug	after one month of administration of drug

Secondary Outcome Measures

Name	Time	Method
IMPROVEMENT IN immunity and overall health condition due to reduction in number of episodes of illness	after 2months of follow up

Trial Locations

Locations (1)

Banaras Hindu University; 🇮🇳 Varanasi, UTTAR PRADESH, India

Banaras Hindu University

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Sahana Shankari

Principal investigator

9741896978

sahanashankari29@gmail.com