| CTRI Number |
CTRI/2021/09/036941 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“A Clinical Study on Swarnaprashan to Establish its Safety in children suffering from recurrent infections" |
|
Scientific Title of Study
|
“An Experimental and Clinical Study on Swarnaprashan to Establish its Safety, antimicrobial activity and to Assess its Immunogenicity Effect after BCG Vaccination†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAHANA SHANKARI |
| Designation |
Ph.D. Scholar |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
DEPARTMENT OF KAUMARBHRITYA/BALROGA
FACULTY OF AYURVEDA
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
VARANASI
DEPARTMENT OF KAUMARBHRITYA/BALROGA
FACULTY OF AYURVEDA
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9741896978 |
| Fax |
|
| Email |
sahanashankari29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B M SINGH |
| Designation |
HOD |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
DEPARTMENT OF KAUMARBHRITYA/BALROGA
FACULTY OF AYURVEDA
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
VARANASI
VIRAT MS APPARTMENTS
VARANASI
UTTARPARADESH
INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7355644462 |
| Fax |
|
| Email |
hodkb2006@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SAHANA SHANKARI |
| Designation |
Ph.D. Scholar |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
DEPARTMENT OF KAUMARBHRITYA/BALROGA
FACULTY OF AYURVEDA
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
VARANASI
DEPARTMENT OF KAUMARBHRITYA/BALROGA
FACULTY OF AYURVEDA
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9741896978 |
| Fax |
|
| Email |
sahanashankari29@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF KAUMARBHRITYA/BALROGA
FACULTY OF AYURVEDA
|
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF KAUMARBHRITYA/BALROGA
FACULTY OF AYURVEDA
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
VARANASI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sahana Shankari |
Banaras Hindu University |
Department of Kaumarbhritya Faculty of Ayurveda IMS BHU
Varanasi
UTTAR PRADESH |
9741896978
sahanashankari29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J06||Acute upper respiratory infectionsof multiple and unspecified sites. Ayurveda Condition: repeated upper respiratory tract infections in children, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
An Experimental and Clinical Study on Swarnaprashan to Establish its Safety, antimicrobial activity and to Assess its Immunogenicity Effect after BCG Vaccination |
This will be a single arm open label Exploratory study with total of 30 patients, of 1-15 years, irrespective of sex suffering with recurrent illness will be selected to assess the morbidity incidence during the study period.
The Swarnaprashan with Swarna bhasma -15 mg, Madhu 2 ml of and 1 ml of Ghrita, will be given once a day for 1 month in early hours of morning (8 to 10 a.m.) after getting written informed consent from the parents. All the cases will be gathered from the Kaumarbhritya - OPD or IPD; S.S. Hospital, IMS, BHU after assessing the following exclusion and inclusion criteria -
dURATION OF STUDY -3 MONTHS
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
a) Neonates and infants <1year and 16 or more than 16 years
b) During any symptomatic illness
c) Suffering from degenerative neurological, IEM, etc.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| IMPROVEMENT IN immunity and overall health condition due to reduction in number of episodes of illness |
after 2months of follow up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
01/10/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 24-08-2021 and end date provided 24-08-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
It will be a single
arm open label Exploratory study including a total
of 30 patients of1-15
years, irrespective of sex suffering with recurrent illness will be selected to assess the
morbidity incidence during the study period. The Swarnaprashan
with Swarna bhasma -15
mg, Madhu 2 ml
of and 1 ml of Ghrita, will be given once a day
for 1 month in early hours of morning (8 to 10 a.m.) after
getting
written informed consent from the parents. All the cases will be gathered from the Kaumarbhritya - OPD
or IPD; S.S. Hospital, IMS, BHU after assessing the following exclusion and
inclusion criteria - 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. Investigations: The
following investigations will be prescribed before and after 1month of drug
administration CBC,
GBP, LFT, RFT, ESR, Urine,
stool Routine, Others
–disease specific like swab, urine, stool for
culture and sensitivity, CT,MRI,X-ray Follow up:: The
patients will be called for follow up at an interval of 15 days for 3 months
and as per the proforma the
episodes of respiratory or any other illness would be recorded. Adverse effect:
any
untoward effects during
the study will
also be recorded and treatment would be stopped in-between and the case would
be dropped and specific treatment will be given to relieve the symptoms. Statistical Analysis:
relevant statistical formula will be used for analysis of data. Then
all Data shall be concluded after categorizing into particular specific part of
the study as experimental, animal, clinical study with the reasoning on the
particular observation with statistical significance. For
data analysis SSPE software will be used in collaboration of Dep’t of Statistics.
|