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CTRI Number  CTRI/2024/10/074712 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To assess the effect of selected ayurvedic treatments in the management of Osteoarthritis knee joint 
Scientific Title of Study   Effect of selected ayurvedic treatment protocol in the management of Osteoarthritis knee joint grade II and III 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANEESA T A 
Designation  PG Scholar 
Affiliation  Govt ayurveda college Thiruvananthapuram 
Address  Department of salyatantra Government ayurveda college Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9847274863  
Fax    
Email  aneesata1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR REMYA VR 
Designation  Assistant professor 
Affiliation  Govt ayurveda college Thiruvananthapuram 
Address  Department of salyatantra Government ayurveda college Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9947035121  
Fax    
Email  remyarenjith3784@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR REMYA VR 
Designation  Assistant professor 
Affiliation  Govt ayurveda college Thiruvananthapuram 
Address  Department of salyatantra Government ayurveda college Thiruvananthapuram


KERALA
695001
India 
Phone  9947035121  
Fax    
Email  remyarenjith3784@gmail.com  
 
Source of Monetary or Material Support  
Govt ayurveda college Thiruvananthapuram , MG road ,Thiruvananthapuram , Kerala , India , Pin : 695001 
 
Primary Sponsor  
Name  Govt ayurveda college 
Address  Govt ayurveda college MG road Thiruvananthapuram 695001 Kerala India  
Type of Sponsor  Other [Govt ayurveda 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 Aneesa T A  Govt ayurveda college Thiruvananthapuram  Salyatantra department OP division room no 3 MG road Thiruvananthapuram 695001 Thiruvananthapuram Kerala
Thiruvananthapuram
KERALA 		 9847274863

aneesata1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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-Rooksha bandhana snehana sveda anulomana brihmana matravasthi (Procedure Reference: Charaka samhitha, Procedure details: Rooksha sveda for 45 min per day for 7 days bandhana to janu for 7 days vicharana snehapana for 14 days per day 2 time pathrapotala sveda 45 min per day for 7 days abhyanga ooshmasveda for 1 day 45 min anulomana for 1 day pizhinju thadaval mathravsthi for 7 days)
(1) Medicine Name: Kolakulathadi choornam, Reference: Charaka samhitha, Route: Topical, Dosage Form: Lepa Churna, Dose: 200(g), Frequency: od, Duration: 7 Days
(2) Medicine Name: Murivenna, Reference: Vamozhi yoga, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: bd, Duration: 7 Days
(3) Medicine Name: Guggulu thikthakam gritham, Reference: Ashtanga hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Duration: 14 Days
(4) Medicine Name: Balathailam, Reference: Ashtanga hridaya, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days
(5) Medicine Name: Balathailam, Reference: Ashtanga hridayam, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 1 Days
(6) Medicine Name: Gandharva erandam thailam, Reference: Ashtanga hridayam, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 1 Days
(7) Medicine Name: Dhanwantharam thailam, Reference: Ashtanga hridayam, Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: od|, Duration:
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group 40 -60 years either sex
Diagnosed case of OA knee joint single or both knee on the basis of clinical signs symptoms and X ray finding according to Kellgren and Lawrence system of classification of OA knee joint grade II and grade III  
 
ExclusionCriteria 
Details  Participants associated with fracture diagnosed by X rays secondary OA and OA with inflammation
Known case of bone cancer
Uncontrolled DM HTN DLP Cardiac diseases Liver diseases Infectious diseases like HIV Hepatitis B 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reducing pain tenderness and improving range of movements  Pain tenderness and range of motion assessed on 0th day 31st day 61st day 91st day and 121st day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="23"
Sample Size from India="23" 
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Above study is to assess the effect of selected Ayurvedic treatment protocol for OA knee grade II and III. Started from Rooksha sveda for 7 days next bandage to affected knee joint for 7 days then pathrapotala sweda for 7 days  after that abhyanga oshmasveda for 1 day then Anulomana given for 1 day finally Pizhuinju thadaval with matravasthi for 7 days. Evaluation is made on reducing pain through VAS parameter tenderness and range of motion of knee joint by a Goniometer. 
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