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CTRI Number  CTRI/2024/10/075474 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective Study 
Study Design  Single Arm Study 
Public Title of Study   Retrospective Study on Health Data from Patients of BeWell Hospital 
Scientific Title of Study   Retrospective Analysis of Healthcare Indices in Patients who received medical care as Inpatients and Outpatients at Be Well Hospitals, Chennai, from 2014 to 2024 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
F61S/MDN/BeWell Version 01 02Aug24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preethy SP 
Designation  Overall Trial Coordinator 
Affiliation  MediNippon Healthcare Private Limited 
Address  Room No 1, Department of Research, Plot no, 6, Zakariah Colony III St., Choolaimedu Chennai

Chennai
TAMIL NADU
600094
India 
Phone  9444927694  
Fax    
Email  drspp@nichimail.jp  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preethy SP 
Designation  Overall Trial Coordinator 
Affiliation  MediNippon Healthcare Private Limited 
Address  Room No 1, Department of Research, Plot no, 6, Zakariah Colony III St., Choolaimedu Chennai


TAMIL NADU
600094
India 
Phone  9444927694  
Fax    
Email  drspp@nichimail.jp  
 
Details of Contact Person
Public Query
 
Name  Dr Preethy SP 
Designation  Overall Trial Coordinator 
Affiliation  MediNippon Healthcare Private Limited 
Address  Room No 1, Department of Research, Plot no, 6, Zakariah Colony III St., Choolaimedu Chennai


TAMIL NADU
600094
India 
Phone  9444927694  
Fax    
Email  drspp@nichimail.jp  
 
Source of Monetary or Material Support  
MediNippon Healthcare Pvt Ltd No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094, Tamil Nadu, INDIA 
 
Primary Sponsor  
Name  MediNippon Healthcare Pvt Ltd 
Address  No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094, Tamil Nadu, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr CJ Vetrievel  BeWell Hospitals Private Limited  Room No 1, Department of Records No2, (Old No 5), Vijayaraghava Road, 1st Street, T. Nagar
Chennai
TAMIL NADU 
9841108873

drvetri@bewellhospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL. Not applicable. 
Intervention  NIL.   NIL. Not applicable. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  o Patients of any age and gender.
o Patients who received medical care as Inpatients and Outpatients at Bewell Hospitals, Chennai, between 01 Jan 2014 and 31 July 2024.
o Availability of medical reports suitable for analysing the markers mentioned in objectives.
 
 
ExclusionCriteria 
Details  o Patients without complete or sufficient medical records.
o Patients who were treated outside the specified timeframe.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To analyze healthcare indices, including but not limited to CBC, ESR, CRP, Differential Blood Count, Liver function test, urine analysis, lipid profile, glucose profile, renal function test, cardiac markers, other inflammatory biomarkers, immunological biomarkers and derivative indices such as NLR, LCR, LeCR, PLR, gut microbiome, metabolites, and amino acids, in patients treated at Bewell Hospitals, Chennai, from 2014 to 2024.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
• To identify correlations between these healthcare indices & health status.
• To identify correlations between these healthcare indices & disease outcomes.
• To establish prognostic markers for various diseases based on these indices.
• To develop strategies for preventive healthcare based on the analysis of these indices.
• To assess the efficacy of treatments based on changes in these healthcare indices.
 
Baseline 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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)   30/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Study Design :  Retrospective, Observational Study

Indication : None

Investigational Product : None, Observational Study

Data Collection Time Points : 01-Jan-2014 to 31-Jul-2024

Primary Outcome Measures : To analyze healthcare indices, including but not limited to CBC, ESR, CRP, Differential Blood Count, Liver function test, urine analysis, lipid profile, glucose profile, renal function test, cardiac markers, other inflammatory biomarkers, immunological biomarkers and derivative indices such as NLR, LCR, LeCR, PLR, gut microbiome, metabolites, and amino acids, in patients treated at Bewell Hospitals, Chennai, from 2014  to 2024

Secondary Outcome Measures : 
To identify correlations between these healthcare indices and health status.
To identify correlations between these healthcare indices and disease outcomes.
To establish prognostic markers for various diseases based on these indices.
To develop strategies for preventive healthcare based on the analysis of these indices.
To assess the efficacy of treatments based on changes in these healthcare indices

Background of the study: Healthcare indices such as Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP), and Differential Blood Count are commonly used for diagnosis and monitoring of various diseases. Moreover, derivative immunological indices such as Neutrophil-to-Lymphocyte Ratio (NLR), Lymphocyte-to-C-Reactive Protein Ratio (LCR), Leucocyte-to-C-Reactive Protein Ratio (LeCR), and Platelet-to-Lymphocyte Ratio (PLR) have emerged as important prognostic markers for various conditions, including infections, inflammatory diseases, and cancers.
The gut microbiome and its metabolites have also garnered attention for their roles in health and disease, influencing immune responses, metabolism, and even mental health. Similarly, amino acid profiles can reflect metabolic states and have been implicated in disease pathogenesis and treatment responses.
This retrospective analysis aims to evaluate these healthcare indices in a diverse patient population treated at Bewell Hospital, Chennai, over a period of 11.5 years. By analyzing these indices, the study intends to develop strategies for enhancing preventive healthcare through awareness creation, education and to establish prognostic markers and treatment efficacy indicators across various diseases in the population which visits a secondary care hospital in an urban setting

Purpose of the Study: This retrospective analysis at BeWell Hospital aims to leverage existing healthcare data to uncover trends and correlations that can improve patient outcomes through better preventive strategies and more effective treatment protocols. The study’s findings have the potential to inform clinical practice and contribute to the broader understanding of healthcare indices and their relevance to disease prognosis and treatment efficacy.

 
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