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CTRI Number  CTRI/2023/02/049745 [Registered on: 15/02/2023] Trial Registered Prospectively
Last Modified On: 14/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   A STUDY ON “INJI CHOORANAM (INTERNAL)”AND VATHA KESARI THAILAM (EXTERNAL) IN THE MANAGEMENT OF THANDAGA VATHAM ( LUMBAR SPONDYLOSIS) 
Scientific Title of Study   AN OPEN NON RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF “INJI CHOORANAM (INTERNAL)”AND VATHA KESARI THAILAM (EXTERNAL) IN THE MANAGEMENT OF THANDAGA VATHAM ( LUMBAR SPONDYLOSIS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Deepa 
Designation  PG Scholar 
Affiliation  National institute of siddha 
Address  Room no:7/8 Department of Maruthuvam National institute of Siddha Tambaram Sanatorium Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9943889203  
Fax    
Email  deepanarayanan1496@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr H Vetha Merlin Kumari 
Designation  Associate Professor  
Affiliation  National institute of siddha 
Address  Room no:7/8 Department of Maruthuvam National institute of Siddha Tambaram Sanatorium Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr N Deepa 
Designation  PG Scholar 
Affiliation  National institute of siddha 
Address  Room no:7/8 Department of Maruthuvam National institute of Siddha Tambaram Sanatorium Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9943889203  
Fax    
Email  deepanarayanan1496@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha Tambaram Sanatorium Chennai 47 
 
Primary Sponsor  
Name  National institute of siddha 
Address  Room no:7/8 Department of Maruthuvam National Institute of Sidddha Tambaram Sanatorium Chennai 600047 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr N Deepa  Ayothidoss Pandithar Hospital  Room no:7/8 Department of Maruthuvam National Institute of Sidddha Tambaram Sanatorium Chennai 600047
Kancheepuram
TAMIL NADU 		 9943889203

deepanarayanan1496@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INJI CHOORANAM(Internal medicine) VATHA KESARI THYLAM(External medicine)  Verugadi alavu(1.250-1500mg) bds 10ml apply externally For 48 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient who are having symptoms of Lower back pain, Excessive sweating, Reduced
range of movements, Body tiredness
2.Patient who are willing to sign informed consent form
3. Patients who are willing to give radiological investigation 
 
ExclusionCriteria 
Details  Known case of,
1.Cardiac disease
2.Auto immune disease like Rheumatoid arthritis, SLE,Psoriasis,Mixed connective tissue
disorders.
3.Spina bifida
4.Osteomyelitis
5.Tuberculosis in spine
6.Pregnancy and lactation
7.Renal diseases
8.Other systemic illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement of Aberdeen low back pain scale scoring before and after treatment.
Comparing the reduction of clinical symptoms before and after treatment  		 2 MONTHS- SCREENING
2 MONTHS- DATA COLLECTION
2 MONTHS- DATA ANALYSIS AND OUTCOME 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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 
Date of First Enrollment (India)   18/02/2023 
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   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   BACKGROUND : This is an open clinical trial that evaluates the effectiveness of Siddha herbal formulation INJI CHOORANAM(INTERNAL) and VATHA KESARI THAILAM (EXTERNAL) in the management of THANDAGA VATHAM (LUMBAR SPONDYLOSIS) patients through Aberdeen low back pain scale and MRI Lumbar Spine before and after treatment. Lumbar spondylosis also termed as lumbar osteoarthritis, disc degeneration, degenerative disc disease. It is found very commonly in those used to heavy work. The degenerative changes are simply a manifestation of increasing age or wear and tear. Low back pain (LBP) affects approximately 60–85% of adults during some point in their lives. 85.5% of individuals aged 45–64 years demonstrate osteophytes within the lumbar spine. Degenerative changes may appear in young individuals without no trauma history.
OBJECTIVE : To estimate the therapeutic efficacy of siddha herbal formulation INJI CHOORANAM ( INTERNAL ) and VATHA KESARI THAILAM ( EXTERNAL ) in the management of THANDAGA VATHAM ( LUMBAR SPONDYLOSIS ) patients through Aberdeen low back pain scale before and after treatment.
 METHODOLOGY : A Total of 10 diagnosed patients of Thandaga vatham (Lumbar spondylosis) within the age limit of 30 -60 years willing to participate in the study ,by signing the consent form will be enrolled in the study. Pregnancy and lactation, Known cases of Cardiac disease, Auto immune disease like Rheumatoid arthritis, SLE, Psoriasis, Mixed connective tissue disorders. Spina bifida, Osteomyelitis, Tuberculosis in spine, Renal diseases, Other systemic illness will be excluded. Assessment in improvement is done through Aberdeen low back pain scale and MRI Lumbar Spine before and after treatment. 
RESULTS AND DISCUSSION : The result will be statistically analyzed. 
 KEY WORDS : Thandaga vatham, Lumbar spondylosis, Inji chooranam, Vatha kesari thailam.  
 
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