| CTRI Number |
CTRI/2026/03/105720 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail on Chitramoola Ennai in the management of Thandagavatham (Lumbar Spondylosis) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF CHITRAMOOLA ENNAI IN THE MANAGEMENT OF THANDAGAVATHAM (LUMBAR SPONDYLOSIS) |
| 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 S KAVITHA |
| Designation |
Pg scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op number 10, Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8124668492 |
| Fax |
|
| Email |
kavithabsms2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sathish Kumar |
| Designation |
Associate professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op number 10, Department of Pothu maruthuvam, Government siddha Medical College and Hopital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9944337757 |
| Fax |
|
| Email |
drpsk_md@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Justus Antony |
| Designation |
Head of the department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op number 10, Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and OPD facilities and central library of Government Siddha Medical College and Hospital,Palayamkottai Tirunelveli 627002,Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Government siddha medical College and hospital |
| Address |
Government Siddha Medical College and Hospital Palayamkottai, Tirunelveli 627002 |
| 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 S KAVITHA |
Government Siddha Medical College and Hospital |
Op No 10,
Department of Pothu Maruthuvam
Tirunelveli
TAMIL NADU |
8124668492
kavithabsms2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI ,TIRUNELVELI 627002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHITRAMOOLA ENNAI |
Dosage - 4 grams ( twice a day) after food for 40 days. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Pain and stiffness in the lumbar region.
Patient presenting with or without radiating pain to lower limb.
Difficulty in range of motion Femoral nerve stretch test-Positive.
Patient who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Osteoarthritis of hip.
Patient undergone spinal surgery.
TB-Spine.
SLE.
Infection.
Rheumatoid arthritis.
Fracture of spine.
Chronic renal and liver disease patients.
Pregnancy and Lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome will be aimed at to
Determine the clinical effectiveness of CHITRAMOOLA ENNAI (INTERNAL) in the management of THANDAGAVATHAM( LUMBER SPONDYLOSIS).
Reduced the pain and stiffness affect site.Improve the range of motion
|
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To collect various Siddha literatures and modern journals for literature review on THANDAGAVATHAM.
To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status.
To perform physicochemical, phytochemical, bio chemical analysis of CHITRAMOOLA ENNAI. To evaluate safety profile for CHITRAMOOLA ENNAI acute and sub-acute toxicity. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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
|
This is a“A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF CHITRAMOOLA ENNAI IN THE MANAGEMENT OF THANDAGAVATHAM (LUMBAR SPONDYLOSIS) after purification of trial drug CHITRAMOOLA ENNAI is prepared and administered at the dosage of 4 grams for 40 days which is given to 40 known lumbar spondylosis patient (20 OP+20 IP patients).The primary outcome will be determine the therapeutic efficacy of CHITRAMOOLA ENNAI in the management of thandaga vatham (Lumbar spondylosis).The secondary out come will be to collect various siddha literatures on THANDAGAVATHAM to perform physicochemical ,phytochemical,biochemical analysis of CHITRAMOOLA ENNAI to evaluate safety profile for acute and sub-acute toxicity of CHITRAMOOLA ENNAI to evaluate pharmacological activities of CHITRAMOOLA ENNAI to study about the prevalence of THANDAGAVATHAM in relationship with diet and lifestyle ,to evaluate siddha parameters(including Envagaithervu ,Neerkuri - Neikuri) changes and dhegi of THANDAGAVATHAM patients during trail period ,to evaluate modern parametric changes in THANDAGAVATHAM to assess the quality of life of THANDAGAVATHAM patients and to document Bio statistical analysis . |