| CTRI Number |
CTRI/2025/09/095322 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study of Kopuranthangi chooranam in the management of Thandagavatham |
|
Scientific Title of Study
|
A clinical study of Kopuranthangi chooranam in the management of Thandagavatham Lumbar spondylosis among patients attending OPD,GSMC, Palayamkottai |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vimaladhithan K |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical College and hospital Palayamkottai Tirunelveli Tamilnadu |
| Address |
Room 11
Department of Noinadal Government Siddha Medical College & Hospital Palayamkottai Tirunelveli Tamilnadu India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7598841726 |
| Fax |
|
| Email |
skvadhithan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Department of Noinadal Government siddha medical College and hospital Palayamkottai Tirunelveli Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
Soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sundararajan |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Department of Noinadal Government siddha medical College and hospital Palayamkottai Tirunelveli Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
Soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu 627002 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical College and hospital |
| Address |
Government Siddha Medical College Palayamkottai Tirunelveli Tamilnadu 627002 |
| 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 |
| Vimaladhithan K |
Government siddha medical College and hospital |
Room 11
Department of Noinadal Government Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu 627002
Tirunelveli
TAMIL NADU |
07598841726
skvadhithan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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 |
Kopuranthangi chooranam |
Ingredients Kopuranthangi
Andrographis echiodes
Dose 2gm bd with cow ghee
Duration 48 days
Route of administration oral route |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with symptoms
Low back pain that radiates to both lower legs.
Stiffness
Limited range of motion
Tingling or numbness in the legs
Weakness in lower limbs
Difficulty walking, bending forward or standing for long periods
Imaging tests showing degeneration, osteophyte formation, disc bulge |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating women
Ankylosis spondylosis
Malignancy
Spinal tuberculosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Kopuranthangi chooranam in the management of Thandagavatham (Lumbar spondylosis) will be evaluated |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prognosis of diseases is assessed using likert scale
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/09/2025 |
| 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="4"
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 clinical study will evaluate the efficacy of Kopuranthangi chooranam in the management of Thandagavatham lumbar spondylosis among patients attending OPD in GSMC , Palayamkottai |