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CTRI Number  CTRI/2025/07/092028 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Understanding the Impact of Aging on Red Blood Cells 
Scientific Title of Study   Application of multimodal Raman tweezers to study biochemical variations in human erythrocytes due to physiological aging of individuals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidya Rastapur 
Designation  Research Scholar  
Affiliation  Manipal Institute of Applied Physics, MAHE, Manipal  
Address  Department/Institute: Manipal Institute of Applied Physics (MIAP), Academic block 5, LG -1, MIT campus, MAHE, Manipal - 576104 Division: Plasmonics laboratory, Room no./Lab no.: L 01

Udupi
KARNATAKA
576104
India 
Phone  7259426214  
Fax    
Email  vidya.dampmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sajan D George 
Designation  Professor and Director , MIAP, MAHE, Manipal  
Affiliation  Manipal Institute of Applied Physics, MAHE, Manipal 
Address  Department/Institute: Manipal Institute of Applied Physics (MIAP), Academic block 5, LG -1, MIT campus, MAHE, Manipal - 576104 Division - Centre for Applied Nanosciences(CAN)

Udupi
KARNATAKA
576104
India 
Phone  7760595726  
Fax    
Email  sajan.george@manipal.edu   
 
Details of Contact Person
Public Query  
Name  Dr Aseefhali Bankapur  
Designation  Associate professor, MIAP, MAHE, Manipal  
Affiliation  Manipal Institute of Applied Physics, MAHE, Manipal 
Address  Department/Institute: Manipal Institute of Applied Physics (MIAP), Academic block 5, LG -1, MIT campus, MAHE, Manipal - 576104 Division: Plasmonics laboratory, Room no./Lab no.: L 01

Udupi
KARNATAKA
576104
India 
Phone  9880622130  
Fax    
Email  asif.bankapur@manipal.edu   
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education(MAHE), Manipal. 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education (MAHE), Manipal 
Address  Manipal Academy of Higher Education, Academic block 5,LG -1, MIT campus, MAHE, Manipal 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vidya Rastapur  Kasturba Medical College, MAHE, Manipal   Department of Biochemistry, Kasturba Medical college, MAHE, Manipal, 576104
Udupi
KARNATAKA 		 7259426214

vidya.dampmpl2023@learner.manipal.edu 
Vidya Rastapur  Manipal Institute of Applied Physics (MIAP), MAHE, Manipal  Academic block 5, LG -1, MIT campus, MAHE, Manipal Division: Plasmonic lab, MIAP/Lap, Room no./Lab no.: L 01
Udupi
KARNATAKA 		 7259426214

vidya.dampmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers aging from 20 years to 60 years  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Application of multimodal Raman tweezers   Participants red blood cells will be analyzed using multimodal Raman tweezers, a non-invasive technique that combines optical trapping and Raman spectroscopy. This enables the characterization of biochemical signatures associated with physiological aging. There is no therapeutic intervention applied;  
Comparator Agent  Natural aging Process   Since the study involves drawing 4ml of intravenous blood, and only a part of the leftover blood sample will be used for the study 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age Range: To facilitate a comparative analysis of aging biomarkers, participants will be selected from distinct Age groups, including young adults (20-39 years), middle-aged individuals (40-59 years), and the elderly (60+ years). We will consider 30 men and 30 women in each group of 60 participants above.
Hemoglobin level: Participants with a minimum hemoglobin level requirement. Male: 13.2 to 16.6 grams per deciliter (g/dL) Female: 11 to 14 g/dL (on average).
 
 
ExclusionCriteria 
Details  Participants undergoing recent medical treatments (e.g., chemotherapy, immunosuppressive therapy, blood transfusions, or vaccinations), those with blood disorders (like anemia or HIV), diabetic patients, and individuals with genetic syndromes affecting blood will be excluded
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
These are the prominent measures used to study the usefulness, associations between the prominent variables, and groups or themes generated at the end of the study.
1. The study will generate a comprehensive Raman spectral dataset from RBCs of individuals spanning different ages. The research is expected to elucidate specific markers indicative of cellular aging by correlating these spectral variations with age.
2. The analysis will provide insights into how Raman spectral variations relate to biochemical parameters for aging. The study will deepen our understanding of how human aging impacts the functionality and detection of molecular and structural alterations in RBCs.
3. Using Raman tweezer setups is a new way to study how individual cells behave as they age. The success of this technology could lead to more advanced experimental designs in future blood-related research.
 		 3 years  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   11/08/2025 
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 study uses Raman spectroscopy with optical tweezers to analyze red blood cells (RBCs) from individuals of different age groups, the study involves 192 healthy participants across different age groups: 60 young (20–39), 60 middle-aged (40–59), and 60 elderly (60+), plus 12 volunteers (6 young and 6 middle-aged) who provide blood samples every three months for three years with routine tests. The Leftover blood samples will be transported from the clinical  lab to the experimental  lab under cold chain conditions to record Raman spectra from 10–15 individual RBCs per participant. Using different laser focal spots(point, donut, and line), the study aims to detect age-related biochemical changes in RBCs. Statistical analysis will classify these changes and relate them to clinical data, preserving the cells’ natural state without invasive procedures. This approach will create a detailed spectral dataset to identify markers of cellular aging and link them to biochemical changes in RBCs. It also offers new insights into how aging affects RBC structure and function, with the potential to advance future blood research using Raman tweezer technology. 
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