| CTRI Number |
CTRI/2025/06/088025 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Precision-Driven Response for Anemia Control and Sustainable Health |
|
Scientific Title of Study
|
Developing & Implementing Effective Intervention Delivery Strategies of the Anemia Mukt Bharat Program 2.0 to Reduce the Prevalence of Anemia Among Vulnerable Populations in Selected Districts of India - An Implementation Research Study (PRAKASH) - Precision-Driven Response for Anemia Control and Sustainable Health |
| Trial Acronym |
PRAKASH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NHRP-2025-00-00002 version 1.1 12.12.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Gupta Bansal |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Room No. 418, Division of RCN, ICMR Hqrs, New Delhi, V Ramalingaswami, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9818312053 |
| Fax |
|
| Email |
priyankaicmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Gupta Bansal |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Room No. 418, Division of RCN, ICMR Hqrs, New Delhi, V Ramalingaswami, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
9818312053 |
| Fax |
|
| Email |
priyankaicmr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gupta Bansal |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Room No. 418, Division of RCN, ICMR Hqrs, New Delhi, V Ramalingaswami, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
9818312053 |
| Fax |
|
| Email |
priyankaicmr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Prasad |
AIIMS Bhopal |
Department of Community & Family Medicine, Saket Nagar, Bhopal - 462020
Sehore
MADHYA PRADESH |
9131303207
pankaj.cfm@aiimsbhopal.edu.in |
| Dr Bhuputra Panda |
KIIT Deemed to be University |
School of Public Health, Campus 5, KIIT-DU, Patia, Bhubaneswar 751024
Kendujhar
ORISSA |
9438597924
bhuputra.panda@gmail.com |
| Dr Ragini Kulkarni |
National Institute for Research in Reproductive and Child Health |
Department of Operational and Implementation Research,
Jehangir Merwanji Street,
Parel, Mumbai - 400012
Thane
MAHARASHTRA |
9820966112
kulkarnir@nirrch.res.in |
| Dr Santosh Kumar Dr Sai Ram |
National Institute of Nutrition |
Division of Maternal and Child Health & Nutrition,Tarnaka, Hyderabad-500007
Adilabad
TELANGANA |
9885767609
drsantoshkumar999@gmail.com |
| Dr Sarmila Mazumder |
Society for Applied Studies |
45, Kalu Sarai,
New Delhi -110016
Faridabad
HARYANA |
011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in |
| Dr Prashant T |
St Johns Research Institute |
Division of Nutrition, 100 Feet Rd, John Nagar, Koramangala, Bengaluru
Koppal
KARNATAKA |
9886006166
prashanth.t@sjri.res.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Bhopal |
Approved |
| Kalinga Institute of Medical Sciences |
Approved |
| National Institute for Research in Reproductive and Child Health |
Approved |
| National Institute of Nutrition |
Approved |
| Society for Applied Studies, New Delhi |
Approved |
| St. John’s National Academy of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anemia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMB 2.0 package |
Anemia Mukt Bharat 2.0 interventions among target beneficiary groups |
| Comparator Agent |
Nil |
Since the study is an Implementation research study there is no comparator. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
Since the study is a community based implementation research study there is no inclusion & exclusion criteria defined |
|
| ExclusionCriteria |
| Details |
Since the study is a community based implementation research study there is no inclusion & exclusion criteria defined |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of anemia in children 6-59 months, adolescents girls, WRA (20-49 years), pregnant women |
3, 9, 18, 30, 36 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of moderate and severe anemia in children 6-59 months, adolescents girls, WRA (20-49 years) and pregnant women |
3, 9, 18, 30, 36 months |
|
|
Target Sample Size
|
Total Sample Size="6750"
Sample Size from India="6750"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This proposed
multistate implementation research study seeks to tackle the persistent issue
of anemia in India by developing and applying a sustainable and scalable model
for its prevention and treatment. The primary goal of the study is to design,
optimize, and implement effective strategies aligned with the Anemia Mukt
Bharat (AMB) 2.0 initiative, to reduce the prevalence of anemia among
vulnerable populations to 20% or less and no severe anemia. The proposed
implementation research (IR) will use a mixed-methods approach (qualitative and
quantitative) for model optimizationand interrupted time-series (ITS)
measurements for the outcome evaluation. |