| CTRI Number |
CTRI/2020/03/024401 [Registered on: 31/03/2020] Trial Registered Prospectively |
| Last Modified On: |
26/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In Hindi - SWARNA PRASHAN YOGA KE PRABHAV KA ADHYAYAN
In English - EFFECT OF SWARNA PRASHAN YOGA IN CHILDREN |
|
Scientific Title of Study
|
Analysis of physicochemical characteristics of swarnaprashan yoga and its clinical effects in paediatric age group |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Verma |
| Designation |
PG scholar |
| Affiliation |
Shri narayan prasad awasthi government ayurveda college raipur chhattisgarh |
| Address |
Shri narayan prasad awasthi government ayurveda college
department of kaumarbhritya bala roga Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India
House Number 24 State Bank Colony Heerapur Road Mahoba Bazar
Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9644999222 |
| Fax |
|
| Email |
shrutiverma9966@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar Gupta |
| Designation |
Reader |
| Affiliation |
Shri narayan prasad awasthi government ayurveda college raipur chhattisgarh |
| Address |
Department of kaumarbhritya bala roga , government ayurveda
college Raipur Chhattisgarh department of kaumarbhritya bala roga
Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India
c-303, barsana enclave hirapur road
Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9990988860 |
| Fax |
|
| Email |
prashantgupta27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Kumar Gupta |
| Designation |
Reader |
| Affiliation |
Shri narayan prasad awasthi government ayurveda college raipur chhattisgarh |
| Address |
Department of kaumarbhritya bala roga , government ayurveda
college Raipur Chhattisgarh department of kaumarbhritya bala roga
Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India
c-303, barsana enclave hirapur road
Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9990988860 |
| Fax |
|
| Email |
prashantgupta27@gmail.com |
|
|
Source of Monetary or Material Support
|
| shri narayan prasad awasthi government ayurved college raipur chhattisgarh |
|
|
Primary Sponsor
|
| Name |
Shruti Verma |
| Address |
department of kaumarbhritya-bala roga shri narayan prasad awasthi
government ayurveda college Raipur Chhattisgarh
|
| Type of Sponsor |
Other [government ayurved 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 |
| Shruti Verma |
Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh |
Out Patient Department Number 07 Department Of Kaumarbhritya Bala Roga Shri Narayan Prasad
Awasthi Government
Ayurveda College
Raipur Chhattisgarh
Raipur
CHHATTISGARH
Raipur
CHHATTISGARH |
9644999222
shrutiverma9966@gmail.com |
|
|
Details of Ethics Committee
|
| 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 human volunteers of paediatric age group |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
swarna bhasma , madhu and ghrita |
swarnaprashan yoga will be given to the healthy human volunteers of paediatric age group on pushya nakshatra of every month for 1 year |
| Comparator Agent |
swarna bhasma madhu and ghrita |
swarnaprashan yoga will be given daily for 60 days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1-healthy children
2-children will be selected irrespective of socioeconomic status |
|
| ExclusionCriteria |
| Details |
1-children suffering from severe disease like cardiovascular disease, liver disease, kidney disease & endocrinal disease
2-children not able to come at regular interval for follow up
3-chronic malnutrition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to analyze the vyadhikshmatva (immunity) in children |
group-1 on zero (0), six month,completion of 12th month
group-2 zero (0), 30days, on completion of 60days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the change in intelligence quotient of children during study |
1year |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/04/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the study is an open label randomized clinical trial on Swarnaprashan Yoga and its clinical effect on paediatric age group . two groups will be taken in the clinical trail, swarnaprashan yoga will be given on the day of pushya nakshatra in every month for duration of one year to Group one while in Group two swarnaprashan yoga will be given daily for 60 days. patients will be selected from OPD of shri khudadad dunga ji government ayurveda hospital Raipur chhattisgarh. Evaluation will be based on subjective and objective parameters.
|