| CTRI Number |
CTRI/2024/10/075400 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Estimating the relationship between external ear morphology and body height to evaluate its efficacy as a distinctive identification feature among 385 individuals. |
|
Scientific Title of Study
|
Deciphering the Morphological Correlation Between Stature and External Ear: An investigative approach in the field of Forensic Science |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Shama Das |
| Designation |
Msc Forensic science student |
| Affiliation |
Kasturba Medical College, MAHE |
| Address |
Department of forensic medicine and toxicology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8147251395 |
| Fax |
|
| Email |
shama.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod C Nayak |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, MAHE |
| Address |
Department of forensic medicine and toxicology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845240393 |
| Fax |
|
| Email |
vinod.nayak@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod C Nayak |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, MAHE |
| Address |
Department of forensic medicine and toxicology, Kasturba Medical College, Manipal
KARNATAKA
576104
India |
| Phone |
9845240393 |
| Fax |
|
| Email |
vinod.nayak@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Eshwar Nagar, Madhav Nagar Manipal, Karnataka -576104, India |
|
|
Primary Sponsor
|
| Name |
M Shama Das |
| Address |
Department of Forensic Medicine and Toxicology, Kasturba Medical College, Manipal |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kasturba Medical College |
Tiger circle road, Madhav Nagar, Eshwar Nagar, Manipal- 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| M Shama Das |
Kasturba Medical College |
Department of Forensic medicine and Toxicology ,Tiger circle road, Madhav Nagar, Eshwar Nagar, Manipal- 576104
Udupi
KARNATAKA |
8147251395
shamadas2111@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 |
Participants with no deformed ears |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Participants within the age of 18-50 years and only males will be included.
2. Participants who are students and professional of MAHE will be included.
3. Participants will be informed about the research study and informed consent will be taken, only the participants who give consents will be included.
4. Participants with no deformed ear will be included.
|
|
| ExclusionCriteria |
| Details |
•Participants with Deformed ears and above the age of 50 years (due to deformities) are excluded.
•Female participants (variations in ear length due to wearing earrings) and male participants wearing earrings are excluded.
•Participants who are not willing to give informed consent will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is the relation between stature and external ear measurements. |
10 months(June 2024- March 2025) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of stature is very important in forensic science to identify a person. |
10 months(June 2024- March 2025) |
| In the case of unknown body, stature estimation is important to identify the person and this can be done by anthropometry measurements of the body parts and morphological variations of external ear. |
10 months(June 2024- March 2025) |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
26/10/2024 |
| 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="0"
Months="5"
Days="12" |
|
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
|
The study will help to determine the relation between stature and external ear and it is conducted on 385 participants between the age 18 - 50 years who are Students and Professional of KMC, Manipal. The stature and external ear measurements such as ear height, ear width, Lobule height, Lobule width will be taken. The data will be calculated using Pearson’s correlation and Spearman’s correlation. |