| CTRI Number |
CTRI/2017/03/008183 [Registered on: 22/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of preparation of gold (an ayurvedic preparation) in preventing diseases in children by promoting immunity |
|
Scientific Title of Study
|
Efficacy of Swarnamrithaprashana on promotion of immunity in children – a randomized double blind clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanna Narasimha Rao |
| Designation |
Principal and CMO |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
SDM College of Ayurveda and Hospital Hassan
BM Road
Tanniruhalla
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja U |
| Designation |
Professor and Head of the dept of Kaumarabhritya |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
SDM College of Ayurveda and Hospital Hassan
BM Road
Tanniruhalla
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
rao.shaila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan Kumar S |
| Designation |
Assistant professor dept of Kaumarabhritya |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
SDM College of Ayurveda and Hospital Hassan
BM Road
Tanniruhalla
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
8197589426 |
| Fax |
|
| Email |
nayanpanaje@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences Karnataka Bengaluru
4th T Block Jayanagar
Bengaluru 560 041
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
BM Road
Thanniruhalla
Hassan Karnataka 573201 India |
| 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 Shailaja U |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
OPD Room No 2
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan
BM Road Tanniruhalla Hassan 573201
Hassan
KARNATAKA |
9448816433
rao.shaila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children of age group 6 to 12 years and not under any sort of medication for last 30 days and whose parents are ready to sign the informed accent form |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sugar syrup (Placebo) |
1 gelatinous capsule orally once daily on empty stomach in morning for 30 days |
| Intervention |
Swarnamrithaprashana |
1 gelatinous capsule orally once daily on empty stomach in morning for 30 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children of age group 6 to 12 years not under any sort of medication for last 30 days and whose parents are ready to sign the informed accent form and allow their children to participate in the clinical trial will be included |
|
| ExclusionCriteria |
| Details |
Children with any acute or chronic systemic disorders will not be considered for the trial |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in serum immunoglobulin G and salivary immunoglobulin A |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Aturabala (with specially designed format) and Blood routine (Hb%, TLC, DLC, ESR and RBC indices) |
60 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Randomized Controlled Double
Blind Two arm Prospective Clinical Trial comparing the efficacy of
Swarnamrithaprashana [containing Swarnabhasma, Honey, Ghee, Yastimadhu (Glycyrrhia
glabra Linn.) Guduchi (Tinospora cordifolia. Wild), Shankhapushpi (Convolvulus
pluricaulis. Choisy), Vaca (Acorus
calamus Linn.), Jatamamsi (Nardostachys jatamansi DC.), Ashwagandha (Withania
somnifera Dunal.), Pippali (Piper longum Linn.), Brahmi (Bacopa monnieri.Linn.)]
/ Placebo (Sugar syrup) administered at a dose of one gelatinous capsule
(0.4ml) daily for 30 days in 200 healthy children of 6 to 12 years age
fulfilling the inclusion criteria. Efficacy of the trial drug and placebo will
be assessed on based on the changes in serum IgG and salivary IgA as primary outcome
measures and changes in Atura bala and routine blood parameters as the
secondary outcome measures. BT and AT values will be taken on 0th day and 60thday of intervention respectively. |