| 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
|
|
|
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
|
|
|
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. |