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CTRI Number  CTRI/2024/03/063450 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 24/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Comparison of medical bandages with two different time durations in Primary Osteoarthritis knee 
Scientific Title of Study   Comparison of efficacy of Kottamchukkadi Upanaha in two different time duration in Primary Osteoarthritis knee-a Randomized Controlled Non-Inferiority 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  Dr Sinjith K P 
Designation  PG Scholar 
Affiliation  Vaidyaratnam P S Varier Ayurveda college Kottakkal 
Address  Department of Panchakarma Vaidyaratnam P S Varier Ayurveda college Kottakkal

Malappuram
KERALA
676501
India 
Phone  6282826353  
Fax    
Email  kpsinjith7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jigeesh P P 
Designation  Professor and HOD 
Affiliation  Vaidyaratnam P S Varier Ayurveda college Kottakkal 
Address  Department of Panchakarma Vaidyaratnam P S Varier Ayurveda college Kottakkal

Malappuram
KERALA
676501
India 
Phone  9447997436  
Fax    
Email  drjigeesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jigeesh P P 
Designation  Professor and HOD 
Affiliation  Vaidyaratnam P S Varier Ayurveda college Kottakkal 
Address  Department of Panchakarma Vaidyaratnam P S Varier Ayurveda college Kottakkal

Malappuram
KERALA
676501
India 
Phone  9447997436  
Fax    
Email  drjigeesh@gmail.com  
 
Source of Monetary or Material Support  
VPSV Ayurveda College Kottakkal 
 
Primary Sponsor  
Name  VPSV Ayurveda college Kottakkal 
Address  VPSV Ayurveda college Kottakkal Edarikode PO Kottakkal Malappuram DT Kerala 676501 
Type of Sponsor  Other [Aided college] 
 
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 Sinjith K P  Vaidyaratnam P S Varier Ayurveda College Hospital Kottakkal  Panchakarma Room 17 Department of Panchakarma Vaidyaratnam P S Varier Ayurveda College Hospital Kottakkal
Malappuram
KERALA 		 6282826353

kpsinjith7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee [IEC] Vaidyaratnam P S Varier Ayurveda College Kottakkal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) (Procedure Reference: Pancakarmam athava sodhana cikitsa and Arogyakalpadrumam, Procedure details: Procedure details: Kottamchukkadi churnam along with hareethaki rind powder, sathapushpa powder and saindhava will be made to paste with chincha patra swarasa and this heated paste applied over knee and wrapped with arka patra. The knee will be bandaged with kora cloth and it will be removed after 3 hours.)
2Comparator ArmProcedure-upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) (Procedure Reference: Pancakarmam athava sodhana cikitsa and Arogyakalpadrumam, Procedure details: Procedure details: Procedure details: Kottamchukkadi churnam along with hareethaki rind powder, sathapushpa powder and saindhava will be made to paste with chincha patra swarasa and this heated paste applied over knee and wrapped with arka patra. The knee will be bandaged with kora cloth and it will be removed after 12 hours.)
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants fulfilling the American College of Rheumatology clinical classification criteria of knee OA
Radiological findings of knee of grade 2 to 4 in Kellgren Lawrence Grading scale
Fit for upanaha
Participants with features of associated ama or kapha
Participants willing to give informed consent
 
 
ExclusionCriteria 
Details  Known cases of RA and other types of arthritis
Known cases of fracture/ligament tear/dislocation/knee joint infection/malignancy
Known cases of dermatological disorders
Uncontrolled Diabetes mellitus FBS greater than or equal to 126 mg/dl on medication
Body mass index greater than equal to 40 kg/m2
Pregnant and lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
WOMAC score  0th and 8th day after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
VAS ranging from 0 to 100mm
Safety by Event evaluation scale 		 Every day 
Range of movement using Goniometer  0th and 8th day after treatment 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   08/03/2024 
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 Applicable 
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   A randomized controlled non inferiority trial is planned to asses efficacy of Kottamchukkadi upanaha done for 3 hours and 12 hours duration in reducing WOMAC total score in Primary Osteoarthritis knee. 54 participants fulfilling the criteria will be taken for the study . They will get allocated  to two groups by computer generated randomization. Participants in group A will be given upanaha for 3hours and group B for 12 hours. Primary assessment will be done with WOMAC total score on 0th and 8th day after treatment. Secondary assessments will be done with VAS scale ranging from 0 to 100mm and safety by Event evaluation scale which will be done on every day and range of movements using Goniometer  which will be done on 0th and 8th day. 
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