| CTRI Number |
CTRI/2026/03/105658 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL TRIAL TO
EVALUATE THE THERAPEUTIC EFFECTIVENESS OF THOKKANAM [ PIDITHAL
AND AZHUTTHAL MURAI ] USING NALVELAI VATHA ENNAI (EXTERNAL) IN
THE MANAGEMENT OF THANDAGA VATHAM [ LUMBAR SPONDYLOSIS ]. |
|
Scientific Title of Study
|
AN OPEN LABELLED NON RANDOMIZED PHASE II CLINICAL TRIAL TO
EVALUATE THE THERAPEUTIC EFFECTIVENESS OF THOKKANAM [ PIDITHAL
AND AZHUTTHAL MURAI ] USING NALVELAI VATHA ENNAI (EXTERNAL) IN
THE MANAGEMENT OF THANDAGA 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 ARPITA BISWAS S |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI |
| Address |
PG SCHOLAR, DEPARTMENT OF PURA MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR
GANA STREET, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9361047785 |
| Fax |
|
| Email |
bswsrpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUJATHA S MDs |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
PROFESSOR AND HEAD OF THE DEPARTMENT, DEPARTMENT OF PURA MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR
GANA STREET, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
sujatharajasekar66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUJATHA S MDs |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
PROFESSOR AND HEAD OF THE DEPARTMENT, DEPARTMENT OF PURA MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR
GANA STREET, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
sujatharajasekar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICALCOLLEGE AND HOSPITAL, PALAYAMKOTTAI |
|
|
Primary Sponsor
|
| Name |
DR ARPITA BISWAS S |
| Address |
PG SCHOLAR,DEPARTMENT OF PURA MARUTHHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR GANA STREET, PALAYAMKOTTAI,TIRUNELVELI,TAMIL NADU,INDIA 627002. |
| Type of Sponsor |
Other [SELF] |
|
|
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 ARPITA BISWAS S |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
PG SCHOLAR,DEPARTMENT OF PURA MARUTHHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGA
GANA STREET, PALAYAMKOTTAI,TIRUNELVELI,TAMIL NADU,INDIA 627002.
Tirunelveli
TAMIL NADU |
9361047785
bswsrpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
THOKKANAM [ PIDITHAL
AND AZHUTTHAL MURAI ] USING NALVELAI VATHA ENNAI |
THOKKANAM [ PIDITHAL
AND AZHUTTHAL MURAI ] USING NALVELAI VATHA ENNAI FOR 7 DAYS FOR 15 TO 20 MINS |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants having symptoms of pain in the lumbar region.
Participants having radiating pain to gluteal and lower limbs.
Participants having stiffness/ muscle spasm present in lumbar region.
Participants having pain during forward bending of spine.
Participants with or without numbness and burning sensation in lower limbs.
Participants with positive signs for the specific lumbar examinations.
Participants who are willing to attend OPD and admission and stay in IPD.
Positive radiological findings (X ray/CT/MRI) for lumbar spondylosis.
Participants with mild to moderate grade of symptoms.
|
|
| ExclusionCriteria |
| Details |
Participants with recent H/O trauma, fracture, dislocation and surgery.
Participants with H/O cardiac diseases.
Participants with severe disc bulge, disc protrusion, disc herniation and disc sequestration.
Autoimmune diseases like rheumatoid arthritis, systemic lupus erythematosus, psoriasis, mixed connective tissue disorders.
Ankylosing spondylitis, Tuberculosis of lumbar spine, cauda equina syndrome, osteomyelitis etc.
Spina bifida and any other deformity of vertebral spine.
Renal calculi.
Pregnancy and lactating women.
Any other serious illness like any other skin disease and skin infection
Participants who need internal medicines. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will help to understand the effectiveness of THOKKANAM using NALVELAI
VATHA ENNAI (EXTERNAL) in the management of THANDAGA VATHAM (LUMBAR
SPONDYLOSIS) and Reduction of pain, muscle spasm, numbness, burning sensation and
increase in range of motion in lumbar spine is assessed by clinical assessments. |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety profile of Thokkanam therapy with NALVELAI VATHA ENNAI
To document the basic siddha diagnostic tool Naadi and Neikuri of the participants before and after treatment. |
7 DAYS |
|
|
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)
|
20/03/2026 |
| 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 Yet Recruiting |
| 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
|
It is an open labelled non randomized phase II clinical trial to evaluate the efficacy of
Trial drug : NALVELAI VATHA ENNAI ( external medicated oil )
External therapy: Thokkanam The 4 types of oil is taken in equal quantity and mixed . Then extract of nalvelai and goat milk is added in required quantity. This mixture is boiled till it attains suitable consistency. |