| CTRI Number |
CTRI/2020/03/023835 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
17/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
The look for investigations that can help in finding the end of treatment in spinal tuberculosis |
|
Scientific Title of Study
|
Evaluation of investigations suitable for the endpoint of treatment in spinal tuberculosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tensubam Tomthin Meetei |
| Designation |
Junior Resident |
| Affiliation |
PGIMER,CHANDIGARH |
| Address |
Department Of Orthopaedics,
PGIMER
Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9402294517 |
| Fax |
|
| Email |
tom.tensubam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvdeep Singh Dhatt |
| Designation |
Additional Professor |
| Affiliation |
PGIMER,CHANDIGARH |
| Address |
Department Of Orthopaedics
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9402294517 |
| Fax |
|
| Email |
sdhatt@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tensubam Tomthin Meetei |
| Designation |
Junior Resident |
| Affiliation |
PGIMER,CHANDIGARH |
| Address |
Department Of Orthopaedics,
PGIMER,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9402294517 |
| Fax |
|
| Email |
tom.tensubam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research ,
Chandigarh |
|
|
Primary Sponsor
|
| Name |
Dr Tensubam Tomthin Meetei |
| Address |
Department Of Orthopaedics,
PGIMER,
Chandigarh-160012 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarvdeep Singh Dhatt |
Department Of Orthopaedics,
PGIMER,
Chandigarh-160012 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tensubam Tomthin Meetei |
Post Graduate Institute of Medical Education and Research |
Department Of Orthopaedics,
PGIMER
Chandigarh-160012
Chandigarh
CHANDIGARH |
9402294517
tom.tensubam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M858||Other specified disorders of bonedensity and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
No Intervention to be done.Only follow up observational study to be done for Spinal Tuberculosis patients receiving anti tuberculous drugs as per Revised National Tuberculosis control Program guidelines,India. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Age more than 18 years and less than 70 years
2) Confirmed cases of Spinal Tuberculosis
3) Patients who have received anti tubercular treatment for at least 6 months |
|
| ExclusionCriteria |
| Details |
1) Age less than 18 years and more than 70 years
2) Associated comorbidities like Diabetes mellitus, Hypertension.
3) Patients who underwent or undergoing surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cured status of spinal tuberculosis following anti tuberculous treatment |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Best investigation for finding the cured status |
18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/03/2020 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is an observational follow up study to evaluate the investigations suitable for finding the endpoint of treatment of spinal tuberculosis.All diagnosed cases of spinal tuberculosis who have received treatment for at least 6 months are enrolled.primary outcome will be cured status at 18 months to be determined by routine blood tests and radiological examinations along with PET scan.Secondary outcome will be to determine the best investigation for finding the cured status.
|