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CTRI Number  CTRI/2025/09/094919 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Combining Ayurvedic & Conventional Care for Better Management of Knee Osteoarthritis  
Scientific Title of Study   Holistic Healing for Knee Osteoarthritis: Comparing Integrated, Standard Medical, and Ayurvedic Care  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitesh Manohar Gonnade 
Designation  Additional Professor 
Affiliation  AIIMS, Jodhpur 
Address  Dept of PMR, All India Institute of Medical Sciences (AIIMS), Basni Phase 2, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9530199967  
Fax    
Email  drniteshgonnade9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nitesh Manohar Gonnade 
Designation  Additional Professor 
Affiliation  AIIMS, Jodhpur 
Address  Dept of PMR, All India Institute of Medical Sciences (AIIMS), Basni Phase 2, Jodhpur


RAJASTHAN
342005
India 
Phone  9530199967  
Fax    
Email  drniteshgonnade9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nitesh Manohar Gonnade 
Designation  Additional Professor 
Affiliation  AIIMS, Jodhpur 
Address  Dept of PMR, All India Institute of Medical Sciences (AIIMS), Basni Phase 2, Jodhpur


RAJASTHAN
342005
India 
Phone  9530199967  
Fax    
Email  drniteshgonnade9@gmail.com  
 
Source of Monetary or Material Support  
ICMR 
 
Primary Sponsor  
Name  Indian council of Medical Research (ICMR) 
Address  Ansari Nagar East, New Delhi-110029 
Type of Sponsor  Government funding agency 
 
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 Nitesh Gonnade  All India institute of Medical Sciences, JODHPUR  room no -p-006 Department of Physical medicine and rehabilitation
Jodhpur
RAJASTHAN 		 9530199967

drniteshgonnade9@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute Of Medical Sciences ,Jodhpur ,Institutional ethics Committee  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
1Comparator ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: , Procedure details: 21 sessions. One session in a day)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age between 30 and 65 years, including males and females both.
Diagnosis of primary osteoarthritis (OA) affecting at least one knee joint.
Kellgren-Lawrence (KL) grading of 1 or 2, indicating mild to moderate OA severity.
Baseline Numeric Rating Scale (NRS) score of more than or equal to 5 out of 10, indicating moderate to severe pain intensity.  
 
ExclusionCriteria 
Details  Secondary arthritis due to systemic inflammatory arthritis.
History of post-traumatic knee osteoarthritis.
Previous total knee replacement (TKR) surgery. Recent corticosteroid use for knee-related conditions.
Prior intra-articular viscosupplementation treatment.
Allergy to allopathic and Ayurvedic medications used in the study.
Concomitant skin disease at the application site of any study intervention.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The study is expected to demonstrate that integrated home-based care could be a feasible alternative in terms of pain reduction, functional mobility, and quality of life for early OA knee patients, with improved gait kinematics and positive changes in epigenetic and biochemical markers, compared to standard medical and conventional ayurvedic treatments.  pain severity assessment ,functional assessment ,joint inflamation will be recorded at baseline,4,8,12,16,20,24 WEEKS, Gait Analysis -baseline,12 & 24 weeks,Biochemical Analysis and Epigenetic analysis -baseline and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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 4 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
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  
Rationale: OA causes difficulty in locomotion, and thus, it becomes an issue to attend hospital care; therefore, integrated care is a need. A literature gap exists in comparing standard allopathic care and Ayurvedic intervention for early OA knee, especially regarding clinical insights, gait kinematics, epigenetics, and biochemical markers.
Novelty: To assess the impact of ayurvedic care from a modern science perspective through infrared thermography, epigenetics, biochemical markers, and gait kinematics. Also, we are developing integrated home-based care utilizing the combination of ayurveda and modern medicine to integrate ayurvedic practices into mainstream OA management.
Objectives:
Primary: To assess the impact of integrated care as compared to standard medical care and conventional ayurvedic care on pain, joint inflammation, ADL, quality of life, and gait kinematics
Secondary: To assess the impact of integrated care as compared to standard medical care and conventional ayurvedic care on epigenetic and blood markers.
Methodology: An open-label comparative study comparing three groups; the total sample size is 300 (100 per group) in the 30-65 age group with primary OA knee (Kellgren grading 1 and 2). Ayurveda group receives tailored treatments, including oral medication and Janubasti; the allopathic group follows international guidelines, and the integrated care group will receive ayurvedic oral medicine with topical diclofenac and portable TENS. The outcome variables will include monthly VAS and CRD pune version WOMAC, infrared thermography assessments and gait analysis at baseline, 12 and 24 weeks. Global methylation analysis for epigenetics and biochemical markers (cytokines) will be assessed at baseline and 24 weeks.
Expected Outcome: The study is expected to demonstrate that integrated home-based care could be a feasible alternative in terms of pain reduction, functional mobility, and quality of life for early OA knee patients, with improved gait kinematics and positive changes in epigenetic and biochemical markers, compared to standard medical and conventional ayurvedic treatments.
 
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