DESIGNING, DEVELOPMENT AND VALIDATION OF AN AUTOMATED JANUBASTI DEVICE WITH THERMAL MODULATION FOR TARGETED MUSCULOSKELETAL THERAPY

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.