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CTRI Number  CTRI/2022/05/042792 [Registered on: 24/05/2022] Trial Registered Prospectively
Last Modified On: 05/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to assess the efficacy of Ayurveda treatment in Jaanu Sandhigatavata (Primary Knee Osteoarthritis) 
Scientific Title of Study   A randomized controlled trial to evaluate the efficacy of multimodal Ayurveda interventions in Jaanu Sandhigatavata (Primary Knee Osteoarthritis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Uma Kumar 
Designation  Professor and Head, Dept of Rheumatology, AIIMS, New Delhi 
Affiliation  AIIMS, New Delhi 
Address  Room No 4076, 4th Floor, Teaching Block, AIIMS, New Delhi

Central
DELHI
110029
India 
Phone  91-11-26594467  
Fax    
Email  umaakumar@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishor Patel 
Designation  Research Officer (Ay.) 
Affiliation  Central Ayurveda Research Institute, New Delhi 
Address  Central Ayurveda Research Institute, Room No.201, 2nd floor, Administrative block, Road no.66, Punjabi Bagh(West), New Delhi.

West
DELHI
110026
India 
Phone  7405403106  
Fax    
Email  kishoreworld007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kishor Patel 
Designation  Research Officer (Ay.) 
Affiliation  Central Ayurveda Research Institute, New Delhi 
Address  Central Ayurveda Research Institute, Room No.201, 2nd floor, Administrative block, Road no.66, Punjabi Bagh(West), New Delhi.

West
DELHI
110026
India 
Phone  7405403106  
Fax    
Email  kishoreworld007@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, 61-65, Institutional Area, Opp. “D” Block, Janakpuri, New Delhi- 110058 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  61-65, Institutional Area, Opp. “D” Block, Janakpuri, New Delhi- 110058. 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Danveer Bhadu  AIIMS  Room No 4076, 4th Floor, Teaching Block, AIIMS, New Delhi
New Delhi
DELHI 		 91-11-26594467

danveerbhadu2000@gmail.com 
Dr Kishor Patel  Central Ayurveda Research Institute  IPD Building, Panchakarma Department, Road No.66, Punjabi Bagh (west), New Delhi-110026
West
DELHI 		 011-25221059

cari.delhi2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC AIIMS  Approved 
IEC CARI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Shah MR et al 2010 , Procedure details: Matra Basti with Ksheerabala Taila for 14 days every two months for 6 months will be administered. Along with Matra Basti, Janu Basti with Dhanwantara taila for 14 days every two months for 6 months will also be administered. Further, oral medications, Laksha Guggulu (1g twice daily with lukewarm water after food) and Muktashukti bhasma (250 mg twice daily with lukewarm water after food) for a period of 180 days will also be given.)
(1) Medicine Name: Ksheerbala Taila, Reference: API Part II Vol I, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days
2Comparator Arm (Non Ayurveda)-Topical NSAIDsTopical NSAIDs will be advised for a period of 180 days
 
Inclusion Criteria
Modification(s)  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients between 40 to 70 years having diagnosed Knee osteoarthritis (OA) as per the ACR criteria with the following parameters will be included in the study:
1.Pain score of at least 2 (Numeric Pain rating scale) in most days of the last month;
2.American College of Rheumatology (ACR) functional status criteria class I, II and III
3.Serum vitamin D level of >30 ng/ml
4.Able and willing to give informed consent

ACR criteria
Pain in knee + Any 3 of the following:
Age > 50 years
Less than 30 minutes of stiffness
Crepitus
Bony tenderness
Bony enlargement
No palpable warmth 
 
ExclusionCriteria 
Details  Patients with the following criteria will be excluded from the study:
1.Grade 4 and above radiographic changes in the affected knee (Kellgren-Lawrence classification)
2.Significant trauma to the knee including arthroscopy within preceding one year
3.History of knee joint replacement
4.BMI≥32 kg/m²
5.History of prior intra-articular corticosteroid or hyaluronic acidadministration within one month of the study
6.On corticosteroids
7.Rheumatoid arthritis, Psoriatic arthritis, Lupus
8.Uncontrolled HTN (>160/100 mm Hg)
9.Uncontrolled DM (HbA1c>8.0)
10.Cardiac, hepatic or renal function impairment
11.History or active malignancy
12.Tendency for occurrence of recurrent renal calculi
13.Hypersensitivity to trial drugs
14.History or active substance abuse/ alcoholism
15.Any contraindication for MRI scan
16.Any other condition that in the opinion of the investigator may compromise the participant’s safety or compliance, interfere with evaluation or preclude completion of the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in knee pain and functional disability from baseline assessed through WOMAC index score  At baseline,30th day, 60th day, 90th day, 120th day, 150th day and 180th day. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in score for pain, stiffness and physical function of WOMAC from baseline
2.Change in the range of motion of knee joint (assessed through goniometer)
3.Change in the score of Numeric Pain rating scale from baseline
4.Change in Pain Disability Index score from baseline
5.Change in health related quality of life from baseline assessed through SF-12 questionnaire
6.Change in inflammatory biomarkers (highly sensitive C-reactive protein, IL-6)
7.Change in the need of Rescue Analgesic medication
8.Change in knee structural changes assessed through MRI
9.Change in Bone mineral density assessed through DEXA scan
10.Incidence of AE/ADR 		 At baseline,30th day, 60th day, 90th day, 120th day, 150th day and 180th day. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/06/2022 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Numerous clinical researches have been carried out to study the effect of various Ayurvedic management strategies for Sandhigatavata. However, most of the published studies dealt with selected modalities of treatment rather than the holistic Ayurvedic line of management. It is required to execute research studies with multimodal components of Ayurvedic treatment for Sandhigatavata (osteoarthritis) with long-term follow-up period. For this study, Panchkarma procedures including Matra Basti and Janu Basti along with oral medications Laksha Guggulu and Muktashukti bhasma have been proposed for the management of Jaanu Sandhigatavata (Primary Knee Osteoarthritis) for a period of 180 days.

 
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