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CTRI Number  CTRI/2026/02/105000 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Development of an Automated Janubasti Device with Controlled Heat Therapy for Knee disorders 
Scientific Title of Study   DESIGNING, DEVELOPMENT AND VALIDATION OF AN AUTOMATED JANUBASTI DEVICE WITH THERMAL MODULATION FOR TARGETED MUSCULOSKELETAL THERAPY 
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 Ameekumari Nitinbhai Chaudhari 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 105 Department of Panchakarma Parul Ayurved Hospital Parul University AP-Limda TAL-Waghodia Vadodara Gujarat Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9979329601  
Fax    
Email  amee9879329601@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Barve 
Designation  Associate Professor  
Affiliation  Parul Institute of Ayurved 
Address  OPD No 105 Department of Panchakarma Parul Ayurved Hospital Parul University AP-Limda TAL-Waghodia Vadodara Gujarat Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8554916745  
Fax    
Email  swati.barve38010@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Mr Anupkumar Chaudhari 
Designation  Incubation Manager 
Affiliation  PIERC, Parul University 
Address  PIERC, BBA Building Ground floor, Parul University, Limda, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9714884399  
Fax    
Email  anupkumar.chaudhari@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved Parul University AP- Limda TAL- Waghodia DIST - Vadodara Gujarat India 391760  
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Faculty of Ayurved Parul University AP-Limda TAL-Waghodia Dist-Vadodara Gujarat India 391760  
Type of Sponsor  Private medical 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 Ameekumari Nitinbhai Chaudhari  Parul Ayurved Hospital  OPD NO 105 Department of Panchakarma Parul Ayurved Hospital Parul University AP- Limda TAL- Waghodia Vadodara Gujarat Vadodara GUJARAT 391760 India
Vadodara
GUJARAT 
9979329601

amee9879329601@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of Ayurved  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
1Comparator ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Classical Book Reference, Procedure details: CLASSICAL PROCEDURE OF JANUBASTI IN OSTEOARTHRITIS FOR 7 DAYS)
(1) Medicine Name: Dashmoola Taila, Reference: Bhaisajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Other than the Classical, Procedure details: JANUBASTI DEVICE FOR JANUBASTI PROCEDURE IN OSTEOARTHRITIS FOR 7 DAYS)
(1) Medicine Name: Dashmoola Taila, Reference: Bhaisajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient age group 30-70 years (both years inclusive)
2.Patient fulfilling diagnostic criteria
3. Patient indicated for Swedana
4. Patient of either Gender irrespective of Caste and Religion 
 
ExclusionCriteria 
Details  1.Patients contraindicated for Swedana
2. H/O trauma/fracture/operation
3. Hypersensitivity of skin 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To design, develop, and validate an automated Janu Basti device with thermal modulation for delivering precise and standardized therapy in patients with musculoskeletal disorders affecting the knee joint   Within 8 months of study we will construct the device
After this in 4 months we will assess its efficacy in osteoarthritis of knee Joint 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical efficacy of the device in comparison to conventional manual Janu Basti with respect to pain relief,joint mobility, and functional improvement  This device will reduce the man power for procedure
This device will help in standardization of procedure in future
The device will be made ready for intervention within 18 months of time 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   01/03/2026 
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 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  

Janu Sandhigata Vata (osteoarthritis of the knee) is a common degenerative musculoskeletal disorder, especially prevalent in the elderly. Janu Basti, a localized Panchakarma procedure involving retention of warm medicated oil over the knee joint, is widely practiced for pain relief and improvement of joint function. However, the conventional manual method has limitations such as inconsistent temperature maintenance, oil leakage, high manpower requirement, and variability in therapeutic outcomes.The present study aims to design, develop, and validate an automated Janu Basti device with thermal modulation to deliver standardized, safe, and reproducible therapy. The device integrates controlled heating, temperature monitoring, leak-proof sealing, and automation to maintain optimal oil temperature throughout the procedure.This study will be conducted in three phases: (1) Sources of data (2) Development of Technical device, and (3)  Validation of device through a randomized, comparative, two-arm interventional clinical pilot study.Phase 1: Sources of data- All classical, modern literature and Contemporary texts including the journals and internet sources about the janubasti procedure and device development will be reviewed and documented for the study.Phase 2: Development of technical device:Methodology for develop device-1. Design the Module 2. Finalisation of Materials 3. Develop the Working Module .Development of Working Module-1. Prototyping Process: a) Concept design and Sketching b) Component Selection c) Prototype Fabrication.Component and Specification: Heating Element - Silicon Based heating pad 20 watt &12 v, Leak Proof Sealing Mechanism- Custom designed silicon - based soft padding, Automation System-Programmable Microcontroller i.e. Arduino, Display Unit- Control Panel, Thermal Sensors(thermostat)- Overheating protection &autoshut-off, Protable frame & casing-Lightweight but durable(Acrylic or PETG or ABS)as per compatibility.Phase 3 :Validation of device: Validation of device will be done by a randomised clinical interventional pilot study.A total of 24 patients diagnosed with Janu Sandhigata Vata will be randomly allocated into two groups: Group A receiving conventional manual Janu Basti and Group B receiving device-based Janu Basti. Dashmoola Taila will be used in both groups for a duration of 7 days.Clinical outcomes will be assessed using subjective criteria  such as Janusandhi Shool (pain), Janusandhi Shotha (swelling), Janusandhi Sphutana (crepitus), Janusandhi Graha(stiffness), Prasarana Akanchana Janya Vedana.and Objective Criteria such as VAS Scale and WOMAC index and range of movement measured with the help of Goniometer. Device performance will be evaluated based on temperature regulation, usability, safety, and patient comfort and its parameters such as Temperature Regulation Accuracy, Uniformity of Oil Temperature, Leak Proof Performance, Device Usability Score, Set up and Operation Time, Portability Index( Weight  + Ease), Anatomical Fit Efficiency, Human Resource Optimization Score, Incidence Of Adverse Events, Skin temperature at application site, Thermal Comfort Level(VAS), Post therapy skin observation.The Effect of the janubasti (Panchakarma therapy) will be assessed based on the following criteria:Assessment of Samyak swedana:1.Sheeta Uparama (Relief of coldness)2. Shoola Uparama(Relief of pain)3. Stambha Nigraha(Relief of stiffness)4. Gaurava Nigraha( Relief of heaviness)5. Mardava(Softness of the body)6. Sweda( Adequate sweating)7.Vyadhihani(Remission of diseases).The study is expected to establish the automated Janu Basti device as a standardized, efficient, and clinically effective alternative to the traditional manual method, improving therapeutic consistency, patient comfort, and optimal utilization of resources in Panchakarma practice.


 
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