CTRI

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CTRI Number

CTRI/2025/03/081844 [Registered on: 06/03/2025] Trial Registered Prospectively

Last Modified On:

18/06/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Evaluating the efficacy of medicated oil bandage and medicated oil gauze application in Knee Osteoarthritis.

Scientific Title of Study

Efficacy of Janu Patch and Janu Pichu Bandhana in Janu Sandhigata Vata: A Non-Inferiority Study

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 Somnath Meher
Designation	PG Scholar
Affiliation	Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Address	Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India Hassan KARNATAKA 573201 India
Phone	7008089150
Fax
Email	somnathsomu3@gmail.com

Details of Contact Person
Scientific Query

Name	Dr B A Lohith
Designation	Professor
Affiliation	Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Address	Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India Hassan KARNATAKA 573201 India
Phone	9886749168
Fax
Email	drlohithpk@gmail.com

Details of Contact Person
Public Query

Name	Dr B A Lohith
Designation	Professor
Affiliation	Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Address	Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India Hassan KARNATAKA 573201 India
Phone	9886749168
Fax
Email	drlohithpk@gmail.com

Source of Monetary or Material Support

SDM College of Ayurveda and Hospital, Thanniruhalla, Hassan 573201

Primary Sponsor

Name	SDM College of Ayurveda and Hospital
Address	Thanniruhalla, Hassan 573201
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 Somnath Meher	SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL	OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, Hassan 573201 Hassan KARNATAKA	7008089150 somnathsomu3@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL	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

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	Janu Patch	(Procedure Reference: -, Procedure details: Janu Patch is prepared with absorbing luke warm Mahanarayana Taila with polyethylene absorbent and applied to affected knee joint for 8hrs per day.) (1) Medicine Name: Mahanarayana Taila , Reference: Bhaishajya Ratnavali Vatarogadhikara Prakaranam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
2	Comparator Arm	Procedure	-	Janu Pichu Bandhana	(Procedure Reference: -, Procedure details: Janu Pichu Bandhana is done with absorbing cotton gauze with luke warm Mahanarayana Taila and applied all around the affected knee joint and bandaged for 8hrs per day.) (1) Medicine Name: Mahanarayana Taila , Reference: Bhaishajya Ratnavali Vatarogadhikara Prakaranam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days

Inclusion Criteria

Age From	30.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Subjects with features of Sandhigata Vata in unilateral or bilateral Janu Sandhi. 2. Subjects willing to sign consent form. 3. Subjects fit to undergo Janu Patch and Janu Pichu Bandhana.

ExclusionCriteria

Details

1. Subjects with any other systemic disorders like HIV, HBsAg.
2. Traumatic cases like fracture.
3. Diagnosed cases of Vatarakta and Amavata.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Subjective Parameters 1. Sandhi Shotha 2. Sandhi Shoola 3. Sandhi Graha 4. Akunchana Prasaranayoh Vedana 5. Sandhi Sphutana 6. Sparsha Asahyatwa Objective Parameters 1. Range of movement: measured using goniometer 2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	7days

Secondary Outcome

Outcome	TimePoints
To improve lifestyle.	15 days

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40"

Phase of Trial

Phase 2

Date of First Enrollment (India)

18/03/2025

Date of Study Completion (India)

17/04/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

17/04/2026

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

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
Modification(s)

In India, Osteoarthritis affects approximately 15 million adults annually, with a prevalence ranging from 22% to 39%. This degenerative joint condition is the most common form of arthritis which causes pain, swelling, and stiffness, significantly impacting a person’s ability to move freely. It affects the entire joint, including surrounding tissues, and is most prevalent in the knees, hips, spine, and hands. Factors contributing to its development includes a history of joint injury or overuse, older age, and being overweight. Notably, 73% of subjects with osteoarthritis are older than 55 years, and 60% are female. In Ayurveda, the disease Sandhigata Vata resembles with Osteoarthritis, which is described under Vata Vyadhi. The knee is the most frequently affected joint, followed by the hip and the hand. The treatment approach for Sandhigata Vata involves specific therapeutic methods, including Snehana (oleation), Upanaha (local poultice), Agnikarma (thermal cauterization), Bandhana (bandaging), and Mardana (massage).

Janu Pichu Bandhana, an external therapeutic procedure where Snehana and Bandhana is done concurrently. It is derived from Shiro Pichu which falls under the category of Moordhni Taila treatments. Among these Moordhni Taila, Pichu is particularly more effective compared to abhyanga (oil massage) and seka (pouring of medicated liquids). Here an effort has been made to modify the conventional Janu Pichu Bandhana in the form of Janu Patch to make it more convenient for application and also to see the effectiveness of Janu Patch with that of Janu Pichu Bandhana. If this Janu Patch demonstrates positive effect on Sandhigata Vata, then it may potentially replace the conventional Janu Pichu Bandhana.

Mahanarayana Taila is derived from a blend of potent herbs and processed in Tila Taila, this therapeutic oil can be used in various ways and offers multifaceted benefits for Vata Rogas. Mahanarayana Taila exhibits Brimhana properties, pacifies Vata dosha, acts as Balya and provides relief from Amaya. Hence, all these positive outcomes make it the gold standard dravya for managing Janu Sandhigata Vata.

Although Janu Pichu Bandhana is widely practiced, there is no sufficient research has been done on this procedure. Thus, for current study Janu Pichu Bandhana and development of Janu Patch is taken for managing Janu Sandhigata Vata.