| CTRI Number |
CTRI/2025/06/088069 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying Lower Back Problems in Sedentary and Active Workers Using MRI Scans. |
|
Scientific Title of Study
|
A cross-sectional analytical study to find structural involvement and changes of Lumbo
sacral spine in sedentary and non-sedentary workers suffering from Katigraha by using
MRI(Magnetic Resonance Imaging) scan. |
| 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 Damini Pundlik Bagul |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research centre, Pune |
| Address |
PDEAS College of Ayurved and Research centre Sharir Rachana
department ground floor Nigdi Pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9167105196 |
| Fax |
|
| Email |
baguldamini.777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Bhanage |
| Designation |
Assistant Professor |
| Affiliation |
PDEAS College of Ayurved and Research centre, Pune |
| Address |
PDEAS College of Ayurved and Research centre Sharir Rachana
department ground floor Nigdi Pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9130099663 |
| Fax |
|
| Email |
mmbhanage@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Bhanage |
| Designation |
Assistant Professor |
| Affiliation |
PDEAS College of Ayurved and Research centre, Pune |
| Address |
PDEAS College of Ayurved and Research centre Sharir Rachana
department ground floor Nigdi Pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9130099663 |
| Fax |
|
| Email |
mmbhanage@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research centre Nigdi Pune |
| Address |
PDEAS College of Ayurved and Research centre Sharir Rachana
department ground floor Nigdi Pune Maharashtra 411044 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Damini Pundlik Bagul |
Ayurved Rugnalaya and sterling and multispeciality hospital nigdi pradhikaran pune |
Ayurved Rugnalaya and
sterling and
multispeciality hospital
nigdi pradhikaran pune
sector 27 opd no 117
kayachikitsa
department Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9167105196
baguldamini.777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Ethics Committe College of Ayurved And Research Centre Akurdi Pune 44 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder. Ayurveda Condition: TRIKAGRAHAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients suffering from chronic (Minimum 1 year) Katigraha who had
done MRI scan of Lumbo-sacral spine will be studied.
2) Patient selection will be irrespective of gender, religion, education
occupation and economical status.
3) Patient age criteria 25 – 60 years. |
|
| ExclusionCriteria |
| Details |
1) Patients having traumatic injuries of spine.
2) Patients suffering from rheumatoid arthritis.
3) Patients suffering from any infections of spine.
4) Known case of TB and HIV.
5) Patients with congenital structural deformities of spine.
6) Patients previously undergone any spinal surgery.
7. Patients contraindicated from MRI-scan.
8. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out any structural involvement and changes in Lumbo-sacral spine in
sedentary and non-sedentary workers suffering from Katigraha by using MRI
scan of Lumbo-sacral Spine. |
1 Time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
10/06/2025 |
| 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="1"
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
|
Katigraha is an Ayurvedic condition characterized by pain, stiffness, and restricted movement in the lower back, primarily due to vitiated Vata in the Kati (lumbosacral) region. With increasing cases of low back pain, especially among sedentary workers, understanding the structural changes in the lumbosacral spine has become essential. This study aims to observe and compare these changes in sedentary and non-sedentary workers suffering from Katigraha using MRI scans. By identifying the affected structures, the research can support more accurate diagnosis and guide personalized treatment approaches, including exercise, diet, and self-management strategies, ultimately improving quality of life and work performance.
|