| CTRI Number |
CTRI/2024/06/069532 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
A prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe the nutritional status of patients with spinal cord injury. |
|
Scientific Title of Study
|
A prospective observational study to assess the nutritional status of the patients with spinal cord injury. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohit Jataywal |
| Designation |
Resident |
| Affiliation |
Pt. B. D. Sharma, Post Graduate Institue of Medical Sciences, Rohtak, Haryana |
| Address |
Department of Orthopaedics, Pt. B. D. Sharma, Post Graduate Institue of Medical Sciences, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7011655401 |
| Fax |
|
| Email |
mohitjataywalcool@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roop Singh |
| Designation |
Senior Professor And Head of Department |
| Affiliation |
Pt. B. D. Sharma, Post Graduate Institue of Medical Sciences, Rohtak, Haryana |
| Address |
Department of Orthopaedics, Pt. B. D. Sharma, Post Graduate Institue of Medical Sciences, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9812733858 |
| Fax |
|
| Email |
drroopsingh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roop Singh |
| Designation |
Senior Professor And Head of Department |
| Affiliation |
Pt. B. D. Sharma, Post Graduate Institue of Medical Sciences, Rohtak, Haryana |
| Address |
Department of Orthopaedics, Pt. B. D. Sharma, Post Graduate Institue of Medical Sciences, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9812733858 |
| Fax |
|
| Email |
drroopsingh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, Pt. B. D. Sharma, Post Graduate Institute of Medical Sciences, Rohtak, Haryana, 124001 |
|
|
Primary Sponsor
|
| Name |
Department of orthopaedics, Pt. B. D. Sharma, Post Graduate Institute of Medical Sciences. |
| Address |
Department of orthopaedics, Pt. B. D. Sharma, Post Graduate Institute of Medical Sciences, Rohtak, Haryana, 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 Mohit Jataywal |
Pt. B. D. Sharma, Post Graduate Institue of Medical Sciences, Rohtak, Haryana |
Department of Orthopaedics, Pt. B. D. Sharma, Post Graduate Institue of Medical Sciences, Rohtak, Haryana
Rohtak
HARYANA |
7011655401
mohitjataywalcool@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T149||Unspecified injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
cases of non-progressive trauma will be added. |
|
| ExclusionCriteria |
| Details |
Patients with non-traumatic spinal cord illnesses and progressive spinal cord illnesses are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of severity of SCI on the nutritional status of the patients.
2. To analyze blood biomarkers of nutrition in SCI patients.
3. To correlate the nutritional status with functional outcome. |
July 2024 to October 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients with acute spinal cord injury will be evaluated at the time of injury i.e. at the time of admission and reevaluated after 6 months for functional outcome. |
at the time of admission and after 6 months follow up |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
10/07/2024 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In India, approximately 1.5 million people live with Spinal cord injury with approximately 20,000 new cases of SCI added every year. As the number of SCI patients with longevity is increasing day by day, therefore a study needs to be undertaken to evaluate the nutritional status of individuals with SCI to intervene accordingly to minimise the complications and improve the quality of life. |