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CTRI Number  CTRI/2026/02/103950 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 15/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on adults with Knee Osteoarthritis to compare the effect of two Ayurvedic medicated ghees, Sarvamayantaka Ghrita and Guggulutiktaka Ghrita, given through enema and oral intake, on symptoms and daily movement ability. 
Scientific Title of Study   AN OPEN LABEL RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE COMBINED EFFICACY OF MATRA BASTI AND SHAMANA SNEHAPANA WITH SARVAMAYANTAKA GHRITA OVER GUGGULUTIKTAKA GHRITA IN JANU SANDHIGATA VATA vis-á-vis KNEE OSTEOARTHRITIS 
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 RAKSHITH KUMAR L 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Kayachikitsa OPD No - 1 JSS Ayurveda Medical College and Hospital 41 E Lalithadripura Road Alanahalli Mysuru Mysuru KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  8217523930  
Fax    
Email  rakshith170717@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr BEENA M D 
Designation  Professor 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Kayachikitsa OPD No - 1 JSS Ayurveda Medical College and Hospital 41 E Lalithadripura Road Alanahalli Mysuru Mysuru KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  9538367282  
Fax    
Email  drpbsreddy@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr BEENA M D 
Designation  Professor 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Kayachikitsa OPD No - 1 JSS Ayurveda Medical College and Hospital 41 E Lalithadripura Road Alanahalli Mysuru Mysuru KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  9538367282  
Fax    
Email  drpbsreddy@yahoo.com  
 
Source of Monetary or Material Support  
Materials required for the treatment Sarvamayantaka Ghrita will be prepared from the GMP certified pharmacy and Guggulutiktaka Ghrita will be Procured from the GMP certified pharmacy. 
 
Primary Sponsor  
Name  Dr RAKSHITH KUMAR L 
Address  Kayachikitsa OPD no 1 JSS Ayurveda Medical College and Hospital 41 E Lalithadripura Road Alanahalli Mysuru Mysore  
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 
Dr RAKSHITH KUMAR L  JSS Ayurveda Medical College and Hospital  Kayachikitsa OPD no 1
Mysore
KARNATAKA 		 08217523930

rakshith170717@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearance Committee Human  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 ArmDrugClassical(1) Medicine Name: SARVAMAYANTAKA GHRITA, Reference: Sahasrayogam, Route: Rectal, Dosage Form: Ghrita, Dose: 75(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: SARVAMAYANTAKA GHRITA, Reference: Sahasrayogam, Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukhoshna Jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: GUGGULUTIKTAKA GHRITA, Reference: Ashtanga Hridaya, Route: Rectal, Dosage Form: Ghrita, Dose: 75(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: GUGGULUTIKTAKA GHRITA, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukhoshna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects fulfilling the diagnostic criteria.
2. Subjects of either gender, aged between 30-70 years, irrespective of socio-economic status.
3. Subjects willing to provide informed consent for the study. 
 
ExclusionCriteria 
Details  1. Subjects with Infections, Neoplasms, Congenital diseases of the Knee Joint, Rheumatoid arthritis, Psoriatic arthritis and Gouty arthritis.
2. Subjects with a history of injury (less than 3 months) and any fractures of the Knee Joint.
3. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in WOMAC score.
 		 Day 0, before treatment
Day 10, after Matra Basti
Day 40, after completion of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
1. Range of Movements of Knee Joint- Flexion and Extension measured using Goniometer.
2. Reduction in Knee Joint swelling measured by girth at superior pole of patella.
3. Reduction in Crepitus.
4. Reduction in Tenderness. 		 Day 0, before treatment
Day 10, after Matra Basti
Day 40, after completion of treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   10/04/2026 
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)  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  

Knee osteoarthritis, comparable to Janu Sandhigata Vata in Ayurveda, is a progressive degenerative joint disorder characterized by pain, swelling, crepitus, and restricted movement. Nearly 45 percent of individuals develop knee osteoarthritis during their lifetime, with over 365 million cases reported globally, making it a major cause of disability in older adults. Long-term dependence on NSAIDs for symptom relief leads to gastrointestinal, renal, and cardiovascular adverse effects, highlighting the need for safer long-term management options  .

Ayurveda considers Basti as the principal therapy for Vata disorders. Matra Basti is suitable for prolonged use and is indicated in Vata Vikara. Sarvamayantaka Ghrita, described in Sahasrayogam, is indicated in eighty types of Vata Roga and contains drugs with anti-inflammatory, analgesic, nourishing, and joint-stabilizing actions. Guggulutiktaka Ghrita, indicated in Sandhigata Vata, acts on pain, inflammation, Ama reduction, and tissue support.

This open-label randomized comparative clinical study evaluates and compares the combined efficacy of Matra Basti and Shamana Snehapana with Sarvamayantaka Ghrita over Guggulutiktaka Ghrita in the management of Janu Sandhigata Vata vis-à-vis knee osteoarthritis, with the aim of identifying an effective and safer Ayurvedic intervention for long-term disease management.

 
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