| CTRI Number |
CTRI/2026/02/105000 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
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| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Medical Device Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Development of an Automated Janubasti Device with Controlled Heat Therapy for Knee disorders |
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Scientific Title of Study
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DESIGNING, DEVELOPMENT AND VALIDATION OF AN AUTOMATED JANUBASTI DEVICE WITH THERMAL MODULATION FOR TARGETED MUSCULOSKELETAL THERAPY |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
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Source of Monetary or Material Support
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| Parul Institute of Ayurved Parul University AP- Limda TAL- Waghodia DIST - Vadodara Gujarat India 391760 |
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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 |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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 | | 2 | Intervention Arm | Procedure | - | 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 |
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Inclusion Criteria
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| 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 |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| 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 |
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Secondary Outcome
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| 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 |
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Target Sample Size
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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" |
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Phase of Trial
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Phase 2/ Phase 3 |
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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 |
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Estimated Duration of Trial
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Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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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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