| CTRI Number |
CTRI/2012/03/002505 [Registered on: 20/03/2012] Trial Registered Retrospectively |
| Last Modified On: |
10/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A STUDY ON IMPROVING IMMUNITY OF INFANTS BY ADMINISTERING GOLD PREPARATION |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL ON SWARNA PRASHANA (GOLD PREPARATION) IN INFANTS W.S.R. TO ITS IMMUNOMODULATORY ACTIVITY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JYOTHY K B |
| Designation |
PhD Scholar |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
DEPARTMENT OF KAUMARABHRITYA
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA
JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9722187970 |
| Fax |
|
| Email |
drjyothysrihari@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S Patel |
| Designation |
Associate Professor and HOD |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
DEPARTMENT OF KAUMARABHRITYA
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA
JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574566 |
| Fax |
|
| Email |
drkspatel2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajagopala S |
| Designation |
Assistant Professor |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
DEPARTMENT OF KAUMARABHRITYA
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA
JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9426953318 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
|
|
Primary Sponsor
|
| Name |
DIRECTOR |
| Address |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA
JAMNAGAR |
| Type of Sponsor |
Research institution |
|
|
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 JYOTHY K B |
OPD NO 15A DEPARTMENT OF KAUMARABHRITYA |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA
Jamnagar
GUJARAT |
9722187970
drjyothysrihari@rediffmail.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 full term infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mixture of Honey and Ghee |
Mixture of 4 drops of Honey and 1 drop of Ghee will be administered once a day in morning for a period of 4 weeks |
| Intervention |
Swarna Bhasma |
Dosage of Swarna Bhasma will be calculated as per Fried s Rule.
Swarna Bhasma will be administered along with 4 drops of Honey and 1 drop of Ghee once a day in morning for a period of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
1.Healthy full term infants aging from 0 Day-12 Months of either sex, irrespective of caste and socio- economic status
2.Birth weight >2.5kg
|
|
| ExclusionCriteria |
| Details |
1.Infants more than 12 months
2.Premature and Post mature babies
3.Infants with congenital abnormalities and those requiring emergency care
4.Infants with any systemic diseases which may turn out to be hindrance during the course of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in Immunological Profile
2. Pattern of growth and development with Anthropometric changes
|
At Baseline and after 4 weeks of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pattern of growth and development with Anthropometric changes
|
At Baseline and after 4 weeks of trial |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/03/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Accepted in PUBMED indexed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a Randomized, Single blind, Parallel group, Active controlled Clinical Trial on Swarna Prashana(Gold Preparation) in infants with special reference to its immunomodulatory activity. The Primary outcome measures are changes in Immunological profile and pattern of growth and development along with anthropometric changes at baseline and after 4 weeks of intervention. |