| CTRI Number |
CTRI/2026/01/100903 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the frequency of different Blood groups in a tribal population of Karnataka |
|
Scientific Title of Study
|
To study the prevalence of Blood group antigens in tribal populations of coastal Karnataka: an observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ojasvi Manchanda |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of Immunohematology and Blood Transfusion, Kasturba Hospital, KMC, Manipal
Department of Immunohematology and Blood Transfusion, Kasturba Hospital, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09535095721 |
| Fax |
|
| Email |
dr.ojasvimanchanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamee Shastry |
| Designation |
Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of Immunohematology and Blood Transfusion, Kasturba Hospital, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9743489837 |
| Fax |
|
| Email |
shamee.girish@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deep Madkaiker |
| Designation |
Assistant Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of Immunohematology and Blood Transfusion, Kasturba Hospital, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9975749849 |
| Fax |
|
| Email |
deep.madkaiker@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
QuidelOrtho India |
| Address |
403, Leela Business Park, Andheri (East)Mumbai 400059 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Ojasvi Manchanda |
Kasturba Hospital, Manipal |
Department of Immunohematology and Blood Transfusion, KMC, Manipal
Udupi
KARNATAKA |
09535095721
dr.ojasvimanchanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
From Koraga tribe of Karnataka |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults (age over 18 yrs) from tribal hamlets of coastal Karnataka (Koraga) who consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Any individuals with history of recent blood transfusion (last 3 months) or
transplant (Hematopoietic stem cell transplant (HSCT)/Bone marrow transplant (BMT))
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
prevalence of different blood group antigens determined and comparisons
between tribal patterns obtained from our study and non-tribal antigens patterns established from an
earlier study from our center |
after testing is complete |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The data collected via the questionnaire(KAP) may expose any gaps in knowledge
about the importance of blood donation so awareness & educational strategies can be
prepared. |
after data collection is complete |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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)
|
22/01/2026 |
| 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="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
|
Blood group antigens play an important role in compatibility testing, yet data on their
prevalence among Indian Tribal communities is limited. This study seeks to establish
ABO, Rh, Kell, Duffy, Kidd, Lewis, MNSs antigen prevalence in Koraga tribe and
compare it to established data among non-tribal populations of Coastal
Karnataka. This study also seeks to assess the knowledge,
attitude and practice towards blood donations to identify gaps in awareness, trends
in attitude and thus help inform tailored education and awareness strategies. Study will be conducted under the guidance of Centre of Indigenous
Population, after obtaining permission from appropriate authorities. Adults from tribal
hamlets will be enrolled during health camps after obtaining informed consent
relevant to vulnerable populations in accordance with the guidelines laid down in the
Declaration of Helsinki. Structured and validated KAP questionnaire will be used to
collect data before and after providing education regarding blood donation. EDTA
Blood samples collected will be tested with commercially available antisera against
Blood group antigens. Data compilation will be done in Microsoft Excel and Analysis
via SPSS. Study Findings will help determine the suitability of non-tribal donor
pools for meeting the tribe’s transfusion needs, support rare donor registry
contributions, and improve transfusion safety through education and extended
antigen phenotyping.
Improved knowledge and positive attitude shifts toward blood donation may foster
sustainable engagement with transfusion services and contribute to better healthcare
outcomes in this vulnerable community. |