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CTRI Number  CTRI/2025/05/086153 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Other (Specify) [Varmam therapy]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   KODUVELI NEI AND VARMAM THERAPY IN THE MANAGEMENT OF THANDAGA VAATHAM (LUMBAR SPONDYLOSIS) - PRE-CLINICAL AND CLINICAL STUDY 
Scientific Title of Study   EVALUATION OF THE THERAPEUTIC EFFECTIVENESS OF KODUVELI NEI AND VARMAM THERAPY IN THE MANAGEMENT OF THANDAGA VAATHAM (LUMBAR SPONDYLOSIS) - PRE-CLINICAL AND CLINICAL STUDY 
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 K Vishnu Priya 
Designation  Ph.D Scholar 
Affiliation  National Institute of Siddha 
Address  Room No.: 15, Department of Varma Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kanchipuram, Tamil Nadu.

Kancheepuram
TAMIL NADU
600047
India 
Phone  7811802844  
Fax    
Email  vishnubsms1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M V Mahadevan 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kanchipuram, Tamil Nadu.

Kancheepuram
TAMIL NADU
600047
India 
Phone  9789633690  
Fax    
Email  mvmresearch2008@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M V Mahadevan 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kanchipuram, Tamil Nadu.

Kancheepuram
TAMIL NADU
600047
India 
Phone  9789633690  
Fax    
Email  mvmresearch2008@gmail.com  
 
Source of Monetary or Material Support  
Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47. 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47. 
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 K Vishnu Priya  National Institute of Siddha  Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47.
Kancheepuram
TAMIL NADU 
7811802844

vishnubsms1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, 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: M479||Spondylosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Arumuga chenduram with Thirikadugu chooranam - internal Laguvidamusti thylam - external  The above mentioned internal and external medication will be given for 28 days 
Intervention  Koduveli nei and Varmam therapy  Koduveli Nei will be given internally foe 9 days. 3 days of drug holiday followed by it 15 days Varmam therapy 
Comparator Agent  Varmam therapy  Varmam therapy for 28 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having two or more clinical symptoms
I.Pain in the lumbar region and pain increased in forward bending
II.Radiating pain to buttocks and lower limbs
III.Stiffness in the lumbar region
IV.Increase in the pain on movements
V.Numbness (Tingling sensation) in the lower limbs
Grade I & II in the radiological findings of lumbar spine
Patient who are willing to involve in the study by signing the consent and fulfilling the condition of performa, who are willing to undergo radiological and blood investigations.
Patient who has Oswestry low back disability questionnaire total score 5-34
 
 
ExclusionCriteria 
Details  •K/C/O Cardiovascular disease.
•K/C/O Autoimmune disease
•K/C/O spinal deformities
•K/C/O of renal diseases
•K/C/O Tuberculosis and other infections in the spine
•H/O Acute trauma/fracture
•Pregnancy and lactating mothers
•Patients with any other serious systemic illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The treatment is considered as effective by the reduction of 9 points in the score measured using Oswestry Lowback Disability Scale.   
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the effectiveness of drug and Varmam therapy in reducing the clinical
symptoms in groups 1 and 2 compared with Standard control (Group 3)
The adverse reactions will be noted in the Adverse Drug reaction form and reported to
the Pharmacovigilance wing in the hospital.
 
 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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/ Phase 3 
Date of First Enrollment (India)   13/05/2025 
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="1"
Months="0"
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  
The aim of the study is to evaluate the preclinical safety, efficacy and therapeutic effectiveness of Koduveli nei and Varmam therapy in the management of Thandaga vaatham (Lumbar spondylosis) with the Oswestry low back disability questionnaire scoring 5 - 34 through randomized controlled clinical trial. After completing the acute and sub-acute toxicity studies of the trial drug, 138 selected patients will be allotted in the study group 1, 2 and 3 through computer generated randomization and envelope concealment allocation method. Before starting the treatment, purgation with Agasthiyar kulumbu – 130 mg at early morning in empty stomach with inji saaru (Ginger juice) will be given for balancing the deranged Uyir thathu and advised to take rest on next day. For Group 1 patients, the patient is treated with Koduveli nei internally for 9 days and then advised patient advised to take oil bath and pathiyam. Followed by this, the Varmam therapy will be given for the patients for 15 days. For Group 2 patients, the Varmam therapy will be given for the patients for 28 days.For Group 3 patients, Arumuga chenduram (internally) and Laguvidamusti thylam (externally) is given. The patients who fail to come regularly for more than 3 days will not be allowed to continue the trial and withdrawn from the study. Weekly once, the clinical assessment and prognosis will be noted in the prescribed proformas. The assessment and other clinical data capturing will be done in the presence of guide and in the supervision of Head of the Department. Laboratory Investigations and Oswestry low back disability Questionnaire will be performed before and after the trial. After the completion of trial period the patients will be advised to visit the OPD for further follow up for two months.  
 
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