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CTRI Number  CTRI/2025/02/081199 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare effectiveness of Janu Basti and Ultrasound therapy in Knee joint Osteo arthritis 
Scientific Title of Study   A Randomised Open Labelled Comparative Clinical STudy to Evaluate the Efficacy of Janu Basti with Mahanarayana Taila in Comparison to Ultrasound Therapy in the Management of Janu Sandhigata Vata vis-a-vis Osteoarthritis of Knee Joint.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrDivyani P Das 
Designation  Post Graduate Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of PG Studies in Panchakarma Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Bengaluru

Bangalore
KARNATAKA
560082
India 
Phone  9148096726  
Fax    
Email  divyanipdas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh Puttur 
Designation  Professor and HOD 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of PG Studies in Panchakarma Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Bengaluru

Bangalore
KARNATAKA
560082
India 
Phone  9448176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrDivyani P Das 
Designation  Post Graduate Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of PG Studies in Panchakarma Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Bengaluru

Bangalore
KARNATAKA
560082
India 
Phone  9148096726  
Fax    
Email  divyanipdas@gmail.com  
 
Source of Monetary or Material Support  
Dr Divyani P Das Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore Karnataka India Pin: 560082 
 
Primary Sponsor  
Name  Divyani P Das 
Address  Department of PG Studies in Panchakarma Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road, Udayapura Bengaluru Karnataka India Pin: 560082 
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 Divyani P Das  Sri Sri College of Ayurvedic Science and Reasearch Hospital  Room No: 8 Panchakarma Department Sri Sri College of Ayurvedic Science and Reasearch Hospital Udayapura Kanakapura Road Bengaluru
Bangalore
KARNATAKA 
9148096726

divyanipdas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL 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
1Intervention ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Acharya GS. Panchakarma Illustrated. 1st ed. Varanasi: Chaukhambha Orientalia; 2006. p. 261, Procedure details: Poorvakarma - Mashapali is applied. Pradhanakarma - Indirectly heated mahanarayana taila is retained for 30 minutes. Paschatkarma - taila & Pali removed followed by mridu Abhyanga)
(1) Medicine Name: Mahanarayana Taila, Reference: Mahanarayana Taila, Reference: Ayurvedic Formulary of India. Part 1. 2nd ed. New Delhi: Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH); [Year of publication]. p. 149-150, Route: Topical, Dosage Form: Taila, Dose: 800(ml), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-Ultrasound TherapyUltrasound gel is applied & therapy is done with ultrasound probe continuously moving in circular motions for 15 minutes for each knee joint
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects between the age group of 21 to 60 years irrespective of gender, religion, occupation, and socioeconomic status.
Subjects presenting with Pratyatma Lakshanas of Janu Sandhigatavata.
Subjects fit for Janu Basti and Ultrasound therapy.
Subjects who are willing to give a written consent for the treatment.
Obesity and diabetes mellitus patients under medications can be included in the study, provided it is controlled. 
 
ExclusionCriteria 
Details  Subjects below 21 years and above 60 years of age.
Subjects unfit for Janu Basti and Ultrasound therapy, including those with skin lesions, cuts, wounds, rashes, or skin diseases.
Conditions associated with fractures and other systemic illnesses that interfere with the treatment protocol.
Subjects with skin diseases and open lesions on knee joints.
Subjects with an established diagnosis of Gouty arthritis and Rheumatoid arthritis.
Pregnant and lactating women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•To evaluate the efficacy of Janu Basti with Mahanarayana Taila in Janu Sandhigatavata on the basis of changes noted in total score in important subjective parameters in the institute’s clinical set up.
•To evaluate the efficacy of ultrasound therapy in Janu Sandhigatavata on the basis of changes noted in total score in important subjective parameters in the institute’s clinical set up.
•To compare the efficacy of Janu Basti with Mahanarayana Taila and ultrasound therapy in Janu Sandhigatavata.
 
1st day: Before commencement of treatment.
8th day: After completion of the treatment.
15th day: 7 days after completion of the treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
   
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/03/2025 
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="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  

      Sandhigatavata is compared with osteoarthritis in contemporary medical science due to the similarities in their symptoms. Janu Sandhigatavata is characterized by symptoms such as pain, stiffness, swelling, crepitus, and reduced range of motion in the knee joint. These symptoms are believed to arise due to an imbalance of Vata Dosha, leading to the accumulation of Ama  and the deterioration of cartilage and synovial fluid in the knee joint The procedures like, Snehana, Swedana, Lepa, Upanaha, Agnikarma are indicated in the cure of Sandhigatavata .Swedana is one of the important Upakrama mentioned for Vata Dosha. As Pradhana Karma, Swedana can be adopted according to the disease condition.

      Ultrasound therapy is used as a complementary treatment in physical therapy regimens focused on managing pain and aiding in the healing of soft tissue injuries. The treatment exerts therapeutic effects through thermal (continuous UST) and non-thermal (pulsed UST) modalities. Continuous UST achieves the thermal effect and is purposed to produce analgesia through temperature elevation, which increases capillary permeability and tissue metabolism, thereby enhancing fibrous tissue extensibility and pain thresholds. Non-thermal effects are achieved by modulating cell membrane permeability, increasing protein synthesis, and activating immune response near the injury site, which may stimulate regeneration of damaged tissue.  Hence for an effective solution, an attempt is made to evaluate and compare Janu Basti with Mahanarayana Taila and ultrasound therapy in the management of Janu Sandhigatavata.

 
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