| CTRI Number |
CTRI/2025/04/085786 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of Low Back Pain improvement assessment questionnaire and mobile application(Thandaga Track) through the sypmtoms mentioned in Siddha system of medicine. |
|
Scientific Title of Study
|
Development and validation of prognostic assessment tool for Low Back Pain (LBP) through Siddha symptomatology and development of Siddha mobile application (Thandaga Track) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ULAGAMADHAVAN M |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room No 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai.
Chennai
TAMIL NADU
600047
India |
| Phone |
09842706576 |
| Fax |
|
| Email |
ulagamadhavanm98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr G J Christian |
| Designation |
Head of the Department |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room No 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai.
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr G J Christian |
| Designation |
Head of the Department |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room No 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai.
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National institute of Siddha, Tambaram Sanatorium, Chennai-600047, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Siddha. |
| Address |
Grand Southern Trunk Road,
Tambaram Sanatorium,
Chennai-600047.
Tamil Nadu. |
| Type of Sponsor |
Research institution |
|
|
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 ULAGAMADHAVAN M |
Ayothidoss Pandithar Hospital, National Institute of Siddha. |
Room No 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National institute of Siddha, Tambaram Sanatorium, Chennai.
Kancheepuram
TAMIL NADU |
09842706576
ulagamadhavanm98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NATIONAL INSTITUTE OF SIDDHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical symptoms of Low Back Pain, along with X-ray, CT or MRI findings associates with Low Back Pain. |
|
| ExclusionCriteria |
| Details |
Patients under 18 and above 70 yrs of age.
Patients who not have willing to participate in the study.
Vulnerable group.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME
It will provide a systematic and standardized prognostic tool for Siddha clinicians, in the form of a scoring, and to develop a mobile application (Thandaga Track) to assess the prognosis of low back pain through Siddha symptomatology, facilitating more precise and effective treatment strategies.
|
Baseline 0th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OUTCOME
It will facilitate the documentation of the siddha prognostic scorings for Low Back Pain in patients undergoing Siddha management.
|
Baseline 0th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/05/2025 |
| 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="0"
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
|
AIM
To develop and validate a Siddha
prognostic tool and to develop mobile application named (Thandaga Track)
for assessing prognosis in LBP patients through the Siddha symptomatology.
OBJECTIVES
PRIMARY
OBJECTIVE
To develop and
validate a Siddha prognostic tool and develop a mobile application for
Siddha clinicians to assess the prognosis of low back pain (LBP) based on
symptomatology from Siddha literature.
SECONDARY
OBJECTIVE
To document the
prognostic scores of Low Back Pain in patients undertaking siddha medication.
STUDY DESIGN
Device development
Pilot study – Cross sectional study METHODOLOGY
A multi-phase method will be used in the development of the Siddha mobile
application for determining the prognosis of low back pain. A comprehensive
literature review of classical Siddha texts will be conducted using key terms
such as “iduppu vali, iduppu vatham muthuku vali, mullanthandu vali,
pittathil vali, nadappathil siramam, kaal vali and muthuku purathil erichal”.
This approach aims to identify symptoms and clinical presentations associated
with low back pain and related conditions as described in traditional Siddha
medicine. A structured assessment scale will be developed based on the
important prognostic markers that are found once this data has been reviewed.
Working along with software engineers, the indicators will be converted into an
easily navigable digital version. Features like prognosis visualization,
automatic scoring, and symptom input will all be included in the application.
In order to improve the application’s accuracy, usability, and clinical
relevance, iterative testing will be conducted with input from Siddha doctors
and patients. Finally, a pilot study will validate its effectiveness in a
real-world clinical setting. OUTCOME
PRIMARY
OUTCOME
It will provide a
systematic and standardized prognostic tool for Siddha clinicians, in the form
of a scoring, and to develop a mobile application (Thandaga Track) to
assess the prognosis of low back pain through Siddha symptomatology,
facilitating more precise and effective treatment strategies.
SECONDARY
OUTCOME
It will facilitate the
documentation of the siddha prognostic scorings for Low Back Pain in patients
undergoing Siddha management.
|