| CTRI Number |
CTRI/2026/04/107449 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Varma Adangal] |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Non Randomized clinical trial on Akkini Chooranam and Narambu Pidikku Ottradam and Varmam Adangal alone in the management of Korai Vatham
(Lumbar Spondylosis) for the patients reporting at Government Siddha Medical college and Hospital Palayamkottai |
|
Scientific Title of Study
|
AN OPEN LABELLED DOUBLE ARM NON-RANDOMISED PHASE II CLINICAL TRIAL, TO COMPARE THE EFFECTIVENESS OF VARMA ADANGAL WITH AKKINI CHOORANAM (INTERNAL), NARAMBU PIDIKKU OTTRADAM (EXTERNAL) IN THE MANAGEMENT OF KORAI VATHAM (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 B JAYASURYA |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital ,Palayamkottai |
| Address |
OP no 14 , PG Department of Varma Maruthuvam , Government Siddha Medical college and hospital , Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9944132714 |
| Fax |
|
| Email |
drjayasuryabalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R KRISHNAMOORTHI |
| Designation |
Associate Professor and HOD of Department of Varma Maruthuvam |
| Affiliation |
Government Siddha Medical College and Hospital ,Palayamkottai |
| Address |
PG Department of Varma Maruthuvam, Government Siddha Medical College and Hospital ,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442545017 |
| Fax |
|
| Email |
arksiddh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R KRISHNAMOORTHI |
| Designation |
Associate Professor and HOD of Department of Varma Maruthuvam |
| Affiliation |
Government Siddha Medical College and Hospital ,Palayamkottai |
| Address |
PG Department of Varma Maruthuvam, Government Siddha Medical College and Hospital ,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442545017 |
| Fax |
|
| Email |
arksiddh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Governemnt Siddha Medical College and Hospital ,Palayamkottai ,Tirunelveli - 627002 , Tamilnadu , India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
OP No 14 PG Department of Varma Maruthuvam 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 JAYASURYA B |
Government Siddha Medical College and Hospital Palayamkottai |
OP no 14 , PG Department of Varma Maruthuvam , Government Siddha Medical College and Hospital ,Palayamkottai , Tirunelveli - 627002
Tirunelveli
TAMIL NADU |
9944132714
drjayasuryabalan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Siddha Medical College |
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 |
| Comparator Agent |
Akkini Chooranam (Internal) and Narambu Pidikku Ottradam (External). |
Internal Medicine Dosage - 2gm bd with honey for 21 days, External Medicine as external application for 7 days. |
| Intervention |
Varma Adangal |
Stimulation of Varma Adangal over the Posterior trunk for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having the symptoms of pain in the middle and low back region,difficulty in bending,
Stiffness around the hip,
Patients included using ODI scale,
Patients who are willing to give radiological investigation and provide blood for lab investigation,
Patients who are willing to participate in this study with the knowledge of potential risks and who are willing to sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
Age: Below 30 Years and Above 70 Years
History of fracture, Ligament injury,
History of Ankylosing spondylitis,
History of Pott s spine,
Pregnancy women and lactating mothers,
Benign and malignant Neoplasm,
Patient with any other Autoimmune Diseases,
Patient who are having the skin disease,
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in lower back pain and stiffness as measured by the Oswestry Disability Index (ODI). |
1,7,14 and 21 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the safety profile and biochemical effects of Akkini Chooranam. |
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)
|
13/04/2026 |
| 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
|
An open labelled double arm non-randomised phase II clinical trial to compare the effectiveness of varma adangal with akkini chooranam (internal) and narambu pidikku ottradam (external) in the management of korai vatham (lumbar spondylosis). Varma adangal will be done for 14 days.
The dosage of internal medicine Akkini chooranam is 2gm bd with honey and will be administered for 21 days and external medicine narambu pidikku ottradam is given over lumbar region for 7 days. The sample size of the study is 40 which will be divided into 2 groups each 20 participants First group will be given Varma adangal only Second group will be given Internal medicine and external ottradam. |