| CTRI Number |
CTRI/2024/06/069599 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study where MRI findings are observed in patients with low back pain or sciatica |
|
Scientific Title of Study
|
Cross Sectional Study To Observe Radiological changes In Gridrasi by Lumbo-Sacral Magnetic Resonance imaging |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poojitha D S |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Roga nidana evam vikriti vijnana Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7760989518 |
| Fax |
|
| Email |
pg22165@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nandesh Mohan P |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Roga nidana evam vikriti vijnana Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7204442020 |
| Fax |
|
| Email |
drnandeshmohan@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nandesh Mohan P |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Roga nidana evam vikriti vijnana Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7204442020 |
| Fax |
|
| Email |
drnandeshmohan@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla
Hassan 573201 Karnataka India
|
|
|
Primary Sponsor
|
| Name |
Sri Dharmastala Manjunatheshwara College of Ayurveda and hospital |
| Address |
BM Road Thanniruhalla hassan 573201 karnataka india |
| Type of Sponsor |
Private 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 Poojitha D S |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
IPD and OPD under all
the departments of Sri
Dharmasthala
Manjunatheshwara
College of Ayurveda
and Hospital BM Road
Thanniruhalla Hassan
Karnataka India 573201
Hassan
KARNATAKA
Hassan
KARNATAKA |
7760989518
pg22165@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of gridhrasi without congenital spinal anomalies, who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy .
2. Congenital spinal abnormalities.
3. Patients contraindicated for radiological investigation – Claustrophobia.
4. People with implants, particularly those containing iron - cardiac pacemakers, cochlear implants.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjects fulfilling the diagnostic and inclusion criteria will be screened and recruited for the study.
Examine the subjects according to the steps mentioned in the case record form and analyze the findings from their Lumbo-Sacral MRI.
List out Lumbo-Sacral pathologies in Gridhrasi with the help of Lumbo-Sacral MRI.
|
outcome will be assessed at the baseline with the case record form and MRI findings |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
List out Lumbo-Sacral pathologies in Gridhrasi with the help of Lumbo-Sacral MRI. & differentiate vataja & vata kaphaja gridhrasi
|
outcome will be assessed at the baseline with the case record form & MRI findings. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
08/07/2024 |
| 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="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
|
Low back pain is one of the common conditions of loco motor system disorder, affects people during their productive life. About 40% cases of low back pain are of radicular in origin and considered under the umbrella of sciatic syndrome. The condition resembles disease Gridhrasi mentioned in Ayurveda. A lumbar spine MRI scan can often confirm the location and type of pathology. It is a costly but valuable tool in diagnosing cases of Low back pain due to spinal stenosis, disc degeneration or herniation, infection, neoplasias, metabolic diseases etc. It is a non-invasive technique with no known harmful effects. In this study an attempt will be made to understand the type and location of different lumbo-sacral pathologies which comes under Gridhrasi. All the relevant data regarding Gridhrasi will be collected from classical texts of Ayurveda, Subjects fulfilling the diagnostic and inclusion criteria will be screened and recruited for the study. Examine the subjects according to the steps mentioned in the case record form and analyze the findings from their Lumbo-Sacral MRI. List out Lumbo-Sacral pathologies in Gridhrasi with the help of Lumbo-Sacral MRI. |