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CTRI Number  CTRI/2025/08/093896 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha
Other (Specify) [Varmam Therapy]  
Study Design  Single Arm Study 
Public Title of Study   Study on the Effectiveness of Varmam Therapy for Treating Knee Osteoarthritis 
Scientific Title of Study   Efficacy of Varmam Therapy for the Management of Osteoarthritis (Knee Joint)- An Open Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Uthrapathi S 
Designation  Research Scholar 
Affiliation  Tamil University 
Address  Dept of Siddha Tamil University Thanjavur, Tamil Nadu India.
Assistant Professor, Sivaraj Siddha Medical College, Siddhar koil road, Thumbathulipatty, Salem
Thanjavur
TAMIL NADU
613010
India 
Phone  09600848924  
Fax    
Email  dr.uthra1991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharathajothi P 
Designation  Professor & HOD 
Affiliation  Tamil University,Thanjavur 
Address  Dept of Siddha Tamil University Thanjavur Tamil Nadu India.

Thanjavur
TAMIL NADU
613010
India 
Phone  9443797156  
Fax    
Email  drbharathajothi@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Bharathajothi P 
Designation  Professor & HOD 
Affiliation  Tamil University,Thanjavur 
Address  Dept of Siddha Tamil University Thanjavur Tamil Nadu India.

Thanjavur
TAMIL NADU
613010
India 
Phone  9443797156  
Fax    
Email  drbharathajothi@gmail.com   
 
Source of Monetary or Material Support  
Sivaraj Siddha Medical College, Siddhar Kovil Road, Thumbathulipatty, Salem Tamil Nadu, India Pincode:- 636 307. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [Self] 
 
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 
Uthrapathi S  Room No:3, Department of Varmam, Puramaruthuvam & Sirappu Maruthuvam OPD  Sivaraj Siddha Medical College,Siddhar Kovil Road, Thumbathulipatty, Salem - 636 307.
Salem
TAMIL NADU 		 09600848924

dr.uthra1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shanmuga Medical Research Foundation Trust  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: , Procedure details: )
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having symptoms of arthritis of one or both knee joints, pain, swelling, stiffness, crepitation, restricted movements of knee joint.
Patients who are willing to undergo radiological investigation, laboratory investigations.
Patients willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 160 days but can opt out of the trial of his/her own conscious discretion. 
 
ExclusionCriteria 
Details  H/o Cardiac diseases
H/o Rheumatoid arthritis
H/o Pregnancy and lactation
H/o Chronic kidney disease
H/o Tuberculosis of knee
H/o Septic arthritis
H/o Gonococcal arthritis
H/o Traumatic pain of knee joint
H/o Patient with any other serious systemic illness 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OUTCOME
To Assess the improvement of Santhuvatham (Osteo Arthritis–Knee joint) by reduce at least 2 or 3 scales from start to end of the study in KOO scale in the duration of 3 months (total number of sessions-36) in each patient, the assessment will be done in the duration period of 0,12th, 23rd, 36th day of sessions  		 PRIMARY OUTCOME
To Assess the improvement of Santhuvatham (Osteo Arthritis–Knee joint) by reduce at least 2 or 3 scales from start to end of the study in KOO scale in the duration of 3 months (total number of sessions-36) in each patient, the assessment will be done in the duration period of 0,12th, 23rd, 36th day of sessions  
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY OUTCOME
To Assess the mental status before & after the varmam therapy management by Patient Health Questionnaire-9 [PHQ-9] & Brief Illness Perception Questionnaire [B-IPQ] in the duration of 3 months (Total number of sessions-36) in each patient. the assessment will be done in the duration period of 0,12th, 23rd, 36th day of sessions. 		 SECONDARY OUTCOME
To Assess the mental status before & after the varmam therapy management by Patient Health Questionnaire-9 [PHQ-9] & Brief Illness Perception Questionnaire [B-IPQ] in the duration of 3 months (Total number of sessions-36) in each patient. the assessment will be done in the duration period of 0,12th, 23rd, 36th day of sessions. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   11/09/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
      Osteoarthritis (OA) is a degenerative, non-inflammatory condition, characterized by destruction of articular cartilage and formation of bone in the joint space.In India 62.35 million people affected in 2019, women are most affected then men. It is 20th common cause of years living with disabilities in India. OA was estimated to be the 10th leading cause of nonfatal burden. The gastrointestinal toxicity, associated cardiovascular, renal risks are the major complications in pharmacological management and also the optimum duration of NSAID therapy is unclear. In topical application of NSAIDs and capsaicin are associated local adverse effects including rash, burning and itching. Intra-articular corticosteroid injections provide short-term pain relief. However, intra articular injections given more frequently than once every four months can result in cartilage and joint damage, as well as increased risk of infection, The American College of Rheumatology, the National Institute for Health and Clinical Excellence and the European League Against Rheumatism recommend non-pharmacologic modalities for the management of knee and hip OA. In Siddha system of medicine, has lot of the literature-based evidence in the management of Osteoarthritis also Pharmacological (Internal, External medicines), Non-Pharmacological (External therapies), in spite of the evidence for its effectiveness is unsatisfactory. The aim of the study is to evaluate the therapeutic efficacy of Varmam therapy.In this study, sample size 100, 11 varmam points are administered to each patient, administration time is 20-25 mins, total number of stimulation of Varmam points - 7 times for each varmam, duration of the study is 1 yr and 6 months
 
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